IRB News May 2023

In This Edition

• Flow-Through Funding
• Employment Opportunities
• New IRB Roster Posted
• Training Corner
• Personnel Updates
• 2023 Research Expo
• Weekly IRB Office Hours

Flow-Through Funding

In an effort to standardize how flow-through funds are documented in IRBNet, we now ask researchers to complete the Sponsor field on the Project Information page using the format [Funding Source] flow-through [Institution] if a study is supported by flow-through funds. For example, if UCSF receives an award from the National Institutes of Health (NIH) and UCSF awards a sub-contract to UC Davis, the researcher should write “NIH flow-through UCSF” in the Sponsor field. Existing studies are not required to update the Project Information page with the new formatting.

Employment Opportunities

The UC Davis IRB Administration has posted three positions for recruitment. The last day to apply is Today, May 5!

Research Compliance Analyst 1

• Number of Positions: 1
• Requisition Number: 52481
• Payroll Title: RSCH CMPLNC ANL 1
• Salary Range: $21.22/hr. – $40.47/hr.
• LINK to posting

Research Compliance Analyst 4

• Number of Positions: 2
• Requisition Number: 52438
• Payroll Title: RSCH CMPLNC ANL 4
• Salary Range: $ 74,600.00/yr. – $141,000.00/yr.
• LINK to posting

New IRB Roster Posted

A new roster of IRB reviewers has been posted on our About Us webpage. This document is oftentimes requested by sponsors of research regulated by the FDA.

Training Corner

In collaboration with the Clinical Research Education Program, the UC Davis IRB will be hosting a training entitled “Developing a Clinical Research Protocol: Avoiding Common Pitfalls and Mistakes” on Wednesday, May 17 at 9:30 AM. This training is appropriate for clinical research staff and investigators alike.

 Click HERE to enroll!

Personnel Updates

We would like to welcome Dan Ehrlich to the IRB Administration staff. Dan joins our team as a non-committee analyst, so he may be reviewing a future submission of yours destined for exempt or expedited review!

2023 Research Expo

The annual UC Davis Research Expo is being held on Wednesday, May 16. The UC Davis Research Expo is a one-day event that showcases the latest research-related insight, resources, opportunities and tools to help you advance your research. The event includes exhibits, presentations, workshops, and opportunities to network with potential collaborators. You are welcome to enjoy the full event or attend portions that are of particular interest.

For more information, including a link to register, please see the Office of Research webpage for this event.

Weekly IRB Office Hours

The IRB holds weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we co-host extended office hours with the Clinical Trials Office (CTO). Please see below for upcoming dates and links:

• May 12 | 12:00 PM–2:00 PM | LINK to join combined IRB + CTO office hours
• May 19 | 12:00 PM–1:00 PM | LINK to join IRB office hours
• May 26 | 12:00 PM–1:00 PM | LINK to join IRB office hours

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IRB News April 2023

In This Edition

• Employment Opportunities
• Training Corner
• Weekly IRB Office Hours

Employment Opportunities

Do you appreciate a well-composed IRB submission? Can you navigate IRBNet with your ears closed? Is your reading comprehension sharp enough that you caught the mistake in the last sentence? If you answered yes to these questions, come join us at the IRB!

IRB Administration will be recruiting several Research Compliance Analyst positions in the near future. We will send out another email with the link to these job listings once posted.

Training Corner

In collaboration with the Clinical Research Education Program, the UC Davis IRB will be hosting the following trainings in April:

Lunch and Learn: Demystifying Data Confidentiality in Clinical Research | Thursday, April 13, 12:00 PM

Click HERE to enroll!

Developing a Clinical Research Protocol: Avoiding Common Pitfalls and Mistakes | Tuesday, April 18, 10:00 AM

Click HERE to enroll!

The Office of Human Research Protections (OHRP) has posted the following helpful presentations for researchers:

Finding the “Key” in “Key Information”

We encourage any researcher who struggles with the “key information” section of the 2018 Common Rule compliant consent templates to check out this training!

The Changing Regulatory Landscape and Genetic Research

This presentation discusses revisions made in the 2018 Common Rule and examines what these changes might mean for genetic and genomic research in the future.

Weekly IRB Office Hours

The IRB holds weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we continue to co-host extended office hours with the Clinical Trials Office (CTO). Please see below for upcoming dates and links:

• April 07 | 12:00 PM–1:00 PM | LINK to join IRB office hours TODAY!
• April 14 | 12:00 PM–2:00 PM | LINK to join combined IRB + CTO office hours
• April 21 | 12:00 PM–1:00 PM | LINK to join IRB office hours
• April 28 | 12:00 PM–1:00 PM | LINK to join IRB office hours

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IRB News March 2023

In This Edition

• Employment Opportunity
• Consent Templates Updated to Comply with NIH Data Management and Sharing Policy
• Weekly IRB Office Hours

Employment Opportunity

Do you appreciate a well-composed IRB submission? Can you navigate IRBNet with your ears closed? Is your reading comprehension sharp enough that you caught the mistake in the last sentence? If you answered yes to these questions, come join us at the IRB!

IRB Administration will be recruiting several Research Compliance Analyst positions in the near future. We will send out another email with the link to these job listings once posted.

Consent Templates Updated to Comply with NIH Data Management and Sharing Policy

In order to comply with the new NIH Data Management and Sharing Policy that went into effect January 2023, the UC Davis IRB has updated all consent templates on our IRB Forms webpage and IRBNet Document Library. Researchers developing new informed consent documents are encouraged to use one of the following templates:

• HRP-502 Template – Exempt Research
• HRP-502 Template for Minimal Risk Specimen Research
• HRP-502 Template for Survey/Interview Research
• HRP-502 Template – General (2018 Common Rule Compliant)

Weekly IRB Office Hours

The IRB holds weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we continue to co-host extended office hours with the Clinical Trials Office (CTO). Please see below for upcoming dates and links:

• March 17 | 12:00 PM–1:00 PM | LINK to join IRB office hours
• March 24 | 12:00 PM–1:00 PM | LINK to join IRB office hours
• March 31 | 12:00 PM–1:00 PM | LINK to join IRB office hours

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IRB News February 2023

In This Edition

• Employment Opportunity
• Phasing Out the General (Not 2018 Common Rule Compliant) Informed Consent Form
• Weekly IRB Office Hours

Employment Opportunity

Do you appreciate a well-composed IRB submission? Can you navigate IRBNet with your ears closed? Is your reading comprehension sharp enough that you caught the mistake in the last sentence? If you answered yes to these questions, come join us at the IRB! IRB Administration is recruiting for a Research Compliance Analyst 3 position.

Click HERE for a link to the job posting.

Phasing Out the General (Not 2018 Common Rule Compliant) Informed Consent Form

In anticipation of the FDA adopting new requirements for informed consent as part of the mandate to harmonize with the 2018 Common Rule, the UC Davis IRB has removed the HRP-502 Template – General (Not 2018 Common Rule Compliant) from our IRB Forms webpage and IRBNet Document Library. Eliminating the use of this informed consent form template will support a smooth transition to the new FDA rule. Researchers developing new informed consent documents are encouraged to use one of the following templates:

• HRP-502 Template – Exempt Research
• HRP-502 Template for Minimal Risk Specimen Research
• HRP-502 Template for Survey/Interview Research
• HRP-502 Template – General (2018 Common Rule Compliant)

No changes to approved consent documents are required at this time. For any NEW studies to be submitted to the UC Davis IRB, we have decided to continue accepting the HRP-502 Template – General (Not 2018 Common Rule Compliant) until the FDA regulations are updated.

Weekly IRB Office Hours

The IRB holds weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we continue to co-host extended office hours with the Clinical Trials Office (CTO). Please see below for upcoming dates and links:

• February 03 | 12:00 PM–1:00 PM | LINK to join IRB office hours
• February 10 | 12:00 PM–2:00 PM | LINK to join combined IRB + CTO office hours
• February 17 | 12:00 PM–1:00 PM | LINK to join IRB office hours
• February 24 | 12:00 PM–1:00 PM | LINK to join IRB office hours

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IRB News January 2023

In This Edition

• Website Update
• Phasing Out the General (Not 2018 Common Rule Compliant) Informed Consent Form
• RNIs and Continuing Review
• Weekly IRB Office Hours

Website Update

The Reporting to the IRB – What You Need to Know webpage ​has gotten a makeover! In addition to clarified guidance about events that require prompt reporting, minor deviations, and reporting requirements for studies operating under a reliance agreement, we have included 19 case studies to help researchers determine if an event is reportable to the IRB.

Please email [email protected] if you would like to test our new page and provide feedback. We need your feedback to make the IRB Administration website as useful to researchers as possible.

Phasing Out the General (Not 2018 Common Rule Compliant) Informed Consent Form

In anticipation of the FDA adopting new requirements for informed consent as part of the mandate to harmonize with the 2018 Common Rule, the UC Davis IRB will be removing HRP-502 Template – General (Not 2018 Common Rule Compliant) from our IRB Forms webpage and IRBNet Document Library this month. Eliminating the use of this informed consent form template will support a smooth transition to the new FDA rule. Researchers developing new informed consent documents are encouraged to use one of the following templates:

• HRP-502 Template – Exempt Research
• HRP-502 Template for Minimal Risk Specimen Research
• HRP-502 Template for Survey/Interview Research
• HRP-502 Template – General (2018 Common Rule Compliant)

No changes to approved consent documents are required at this time. For any NEW studies to be submitted to the UC Davis IRB, there will be a grace period during which HRP-502 Template – General (Not 2018 Common Rule Compliant) will continue to be accepted. A final cut-off date for the use of this template will be announced at a future time.

RNIs and Continuing Review

In an effort to allow for the use of “anniversary dates” for continuing review applications, the UC Davis IRB requests researchers no longer combine reportable new information (RNI) submissions and continuing review submissions. If you must report new information to the IRB when continuing review is pending, submit a separate RNI package to ensure you are meeting deadlines for prompt reporting.

Please note, a Project Events Summary Table should still be included in your continuing review submission as applicable.

Weekly IRB Office Hours

The IRB holds weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we will continue to co-host extended office hours with the Clinical Trials Office (CTO). Please see below for upcoming dates and links:

January 6 | 12:00 PM–1:00 PM

LINK to join IRB office hours

January 13 | 12:00 PM–2:00 PM

LINK to join combined IRB + CTO office hours

January 20 | 12:00 PM–1:00 PM

LINK to join IRB office hours

January 27 | 12:00 PM–1:00 PM

LINK to join IRB office hours

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IRB News December 2022

In This Edition

• Holiday Closure
• Weekly IRB Office Hours
• IRB Quality Control Program

Holiday Closure

IRB Administration will be operating with limited staff Friday, December 23, 2022 through Monday, January 2, 2023. We will re-open Tuesday, January 3, 2023. Additionally, we historically see a large influx of submissions in January. As such, you may experience longer than typical processing times for IRB submissions.

If you require a determination from the IRB during the winter holidays or early 2023, please plan ahead and submit early. In addition, make sure to include any relevant deadlines for research activities, so that reviews may be prioritized appropriately.

During the holiday closure, please call (530) 304-1226 or email [email protected] for any urgent issues.

Weekly IRB Office Hours

The IRB holds weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we will continue to co-host extended office hours with the Clinical Trials Office (CTO). Please see below for upcoming dates and links:

December 9 | 12:00 PM–2:00 PM

LINK to join combined IRB + CTO office hours

December 16 | 12:00 PM–1:00 PM

LINK to join IRB office hours

December 23 | No Office Hours (Holiday)

December 30 | No Office Hours (Holiday)

IRB Quality Control Program

In an effort to ensure consistency in the review process and accuracy in documentation, IRB Administration has implemented a new quality control program.

The first phase of the quality control program is focused on IRBNet data entry corrections. For example, correction of an initial approval date from 09/03/3021 to 09/03/2021. During this process, you may receive notification of changes to review details or published board documents. No action is required from submitters during this process.

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IRB News November 2022

In This Edition

• Holiday Closure
• Weekly IRB Office Hours
• PRIM&R Virtual Annual Conference

Holiday Closure

IRB Administration will be operating with limited staff Friday, December 23, 2022 through Monday, January 2, 2023. We will re-open Tuesday, January 3, 2023. Additionally, we historically see a large influx of submissions in January. As such, you may experience longer than typical processing times for IRB submissions.

If you require a determination from the IRB during the winter holidays or early 2023, please plan ahead and submit early. In addition, make sure to include any relevant deadlines for research activities, so that reviews may be prioritized appropriately.

During the holiday closure, please call (530) 304-1226 or email [email protected] for any urgent issues.

Weekly IRB Office Hours

The IRB has decided to hold weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we will continue to co-host extended office hours with the Clinical Trials Office (CTO). Please see below for upcoming dates and links:

November 11 | No Office Hours (Holiday)

November 18 | 12:00 PM–1:00 PM

LINK to join IRB office hours

November 25 | No Office Hours (Holiday)

December 2 | 12:00 PM–1:00 PM

LINK to join IRB office hours

PRIM&R Virtual Annual Conference

The 2022 PRIM&R Annual Conference will be held virtually December 12-15.

This conference offers wide variety of sessions geared toward those working in human subjects research, animal care and use, or institutional leadership, as well as sessions on crossover topics. For more information, including a link to register for this event, please see the 2022 PRIM&R Annual Conference webpage.

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IRB News October 2022

In This Edition

• Pregnant Partner Consent Update
• Contacting the IRB
• IRBNet Document Wizard Reminder
• Training Corner
• Weekly IRB Office Hours NEW
• Website Updates
• OHRP Research Community Forum

Pregnant Partner Consent Update

To avoid unnecessary submission of the pregnant partner consent form template, the UC Davis IRB has decided to remove this template from our IRB Forms webpage. If the partner of a subject participating in a clinical trial becomes pregnant, please contact the UC Davis IRB to request the most updated version of the pregnant partner consent form template. The completed template should be submitted as part of a modification.

Contacting the IRB

While UC Davis IRB Administration has both a phone line and an email account dedicated to providing support, assistance, and guidance to UC Davis researchers, the preferred method of contact is email. If your project has already been submitted to the UC Davis IRB, please do not forget to include the IRBNet ID number for reference!

• Help Desk Email: [email protected]

Help Desk Phone Number: (916) 703-9158

IRBNet Document Wizard Reminder

The Initial Review Application and Post-Approval Submission Form are both online data entry forms to be completed on IRBNet. IRBNet refers to these forms as document wizards. Sometimes updates to these document wizards are required as part of a response to a full committee review or a post-approval submission (i.e., modification, reportable event, continuing review, or closure). To make edits to the Initial Review Application or Post-Approval Submission Form, please do not start new document wizards. Instead, follow the steps below:

1. Log into IRBNet and click the project title.
2. Click “Create a New Package” from the menu on the left side of the screen.
3. Locate the Initial Review Application or Post-Approval Submission Form that you previously submitted in the “Documents from Previous Packages that you can Revise” list.
4. Click the pencil icon.

Note: If you have already created a new package that has yet to be submitted, you may edit these document wizards at any time by navigating to the “Designer” page.

This process will allow you to create a new version of the document wizard in your current package. The new version will automatically retain all of the information previously entered into the document wizards so you only need to update the information that has changed.

Training Corner

In collaboration with the Clinical Trials Office’s Clinical Research Education Program, we will be offering the following trainings via Zoom this month:

New Submitter Training

Thursday, October 13 from 10:00 to 11:30 AM

LINK to register

IRB Reporting Requirements: Minor Deviations and Reportable Events

Thursday, October 27 from 1:00 to 2:30 PM

LINK to register

Weekly IRB Office Hours NEW

The IRB has decided to hold weekly drop-in virtual office hours every Friday from 12:00 PM – 1:00 PM. On the second of Friday of each month, we will continue to co-host extended office hours with the Clinical Trials Office (CTO) from 12:00 PM – 2:00 PM. Please see below for upcoming dates and links:

October 14, 12:00 PM–2:00 PM

LINK to join combined IRB + CTO office hours

October 21, 12:00 PM–1:00 PM

LINK to join IRB office hours

October 28, 12:00 PM–1:00 PM

LINK to join IRB office hours

November 4, 12:00 PM–1:00 PM

LINK to join IRB office hours

Website Updates

The Continuing Review/Closure webpage ​has gotten a makeover! This page has been updated to provide step-by-step instructions for submitting Continuing Reviews and Closures, including information about how to re-open a closed study.

Please email [email protected] if you would like to test our new pages and provide feedback. We need your feedback to make the IRB Administration website as useful to researchers as possible.

OHRP Research Community Forum

Join us in Reno October 25-26, for a two-day Research Community Forum presented by the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), University of Nevada, Reno, University of Nevada, Las Vegas and University of California, Davis.

The purpose of this program is to provide information to Institutional Review Board (IRB) members, IRB administrators, clinical investigators, research support staff, research sponsors, contract research organizations, government regulators, and members of the clinical research community about current issues regarding the protection of human subjects. For more information, including a link to register for this event, please see our OHRP Research Community Forum webpage.

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IRB News September 2022

In This Edition

• Job Opportunities
• Training Corner
• Website Updates
• OHRP Research Community Forum

Job Opportunities

Do you appreciate a well-composed IRB submission? Can you navigate IRBNet with your ears closed? Is your reading comprehension sharp enough that you caught the mistake in the last sentence? If you answered yes to these questions, come join us at the IRB! IRB Administration is recruiting two Research Compliance Analyst 3 positions.

For full consideration, apply HERE by September 6.

Training Corner

Drop-In Office Hours

IRB and Regulatory Virtual Office Hours are being held September 9, from 12:00 PM – 2:00 PM. Stop by to ask your questions about submitting to the IRB and any other questions about human subjects research regulations.

LINK https://ucdavis.zoom.us/j/95513002981

Upcoming Trainings

Please look out for future emails with more information about signing up for the following trainings:

• New Submitter Training

Thursday, October 13 from 10:00 to 11:30 AM

• IRB Reporting Requirements: Minor Deviations and Reportable Events

Thursday, October 27 from 1:00 to 2:30 PM

Website Updates

The Medical Records and Single IRB and Reliances webpages ​have gotten a makeover! The new Medical Records page has been designed to make it easier for researchers to understand how to maintain HIPAA compliance in the course of conducting research. The Single IRB and Reliances page now includes helpful definitions and recordings of previous reliance trainings.

Please email [email protected] if you would like to test our new pages and provide feedback. We need your feedback in order to make the IRB Administration website as useful to researchers as possible.

OHRP Research Community Forum

Join us in Reno October 25-26, for a two-day Research Community Forum presented by the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), University of Nevada, Reno, University of Nevada, Las Vegas and University of California, Davis.

The purpose of this program is to provide information to Institutional Review Board (IRB) members, IRB administrators, clinical investigators, research support staff, research sponsors, contract research organizations, government regulators, and members of the clinical research community about current issues regarding the protection of human subjects. For more information, including a link to register for this event, please see our OHRP Research Community Forum webpage.

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Active Recruitment: Research Compliance Analyst 3

Two IRB Research Compliance Analyst 3 positions have posted for recruitment.

Brief Description

Use skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies/procedures to apply federal, state and university regulations, policies, and guidelines during the review of IRB applications and documents in support of the UC Davis Human Research Protection Program (HRPP). Interact frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of diplomacy, independent judgement, analysis of information, knowledge of standards and best practices, and clear communication to resolve a wide range of research compliance issues related to human subjects protections. Use good judgement in selecting methods and techniques for resolving issues. Ensure applications and review documentation are free of errors or omissions that may ultimately place research participants at undo risk and/or compromise the institutions assurance of regulatory compliance with the federal government.

For Full Consideration Apply By: 9/6/2022

Requisition Number:  41560

Payroll Title:  RSCH CMPLNC ANL 3

Department: IRB ADMINISTRATION 061811

Salary Range: $66,600/yr. – $125,800/yr.

Quick Link To This Position: https://careerspub.universityofcalifornia.edu/psp/ucdavis/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&JobOpeningId=41560&PostingSeq=1&SiteId=7&languageCd=ENG&FOCUS=Applicant

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August 5, 2022

In this edition

• Training Corner
• Continuing Review Updates
• Job Opportunities
• OHRP Research Community Forum

Training Corner

Drop-In Office Hours

IRB and Regulatory Virtual Office Hours are being held Friday, August 12, from 12:00 PM – 2:00 PM. Stop by to ask your questions about submitting to the IRB and any other questions about human subjects research regulations.

Continuing Review Updates

The UC Davis IRB is implementing a practice to maintain the “anniversary date” for IRB expiration dates. The purpose of this change is to ensure a full year or IRB approval and improve compliance by maintaining a consistent expiration date for the life of a study.

How Does it Work?

• The continuing review is submitted in IRBNet by the administrative due date, which is 45 days prior to the expiration date.
• The IRB reviews the continuing review within 30 days of the expiration date.
• The expiration date remains the same every year.

For example…

IRB approval of a study is set to expire on November 1, 2022. The continuing review progress report is submitted by the administrative due date of September 17, 2022. The IRB reviews the submission between October 2, 2022 and November 1, 2022. Upon approval, the study expiration date is extended to November 1, 2023. The administrative due date and project expiration dates will be the same for each subsequent year the project is open.

Modifications and Continuing Reviews

At the time of continuing review, the IRB may require changes to study documents. Examples of IRB-required changes include updated research personnel lists, sponsor information, enrollment numbers, conflict of interest disclosures, and 21^st Century Cures Act language. These IRB-required changes should be included in the continuing review submission, as they are required to secure approval. Additional modifications beyond what was described in this section should be submitted as a separate modification submission. This is to ensure timely review and approval of both the modification and the continuing review.

The IRB requests that researchers no longer combine modification and continuing review submissions, unless the modification is required as part of the continuing review.

Job Opportunities

Do you appreciate a well-composed IRB submission? Can you navigate IRBNet with your ears closed? Is your reading comprehension sharp enough that you caught the mistake in the last sentence? If you answered yes to these questions, come join us at the IRB! IRB Administration will be recruiting several Research Compliance Analyst positions in the near future. We will send out another email with the link to these job listings once posted.

OHRP Research Community Forum

Join us in Reno October 25-26, for a two-day Research Community Forum presented by the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), University of Nevada, Reno, University of Nevada, Las Vegas and University of California, Davis. The purpose of this program is to provide information to Institutional Review Board (IRB) members, IRB administrators, clinical investigators, research support staff, research sponsors, contract research organizations, government regulators, and members of the clinical research community about current issues regarding the protection of human subjects. For more information, including a link to register for this event, please see our OHRP Research Community Forum webpage.

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June 13, 2022

In this edition

• Training Corner
• OHRP Research Community Forum
• Job Opportunities
• Submission Turnaround Time
• UC BRAID Guidelines and Best Practices for Multisite Participant Recruitment Using EMR

Training Corner

Drop-In Office Hours

IRB and Regulatory Virtual Office Hours are being held today, June 10, from 12:00 PM – 2:00 PM. Stop by to ask your questions about submitting to the IRB and any other questions about human subjects research regulations.

OHRP Research Community Forum

Join us in Reno October 25-26, for a two-day Research Community Forum presented by the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP), University of Nevada, Reno, University of Nevada, Las Vegas and University of California, Davis. The purpose of this program is to provide information to Institutional Review Board (IRB) members, IRB administrators, clinical investigators, research support staff, research sponsors, contract research organizations, government regulators, and members of the clinical research community about current issues regarding the protection of human subjects. For more information, including a link to register for this event, please see our OHRP Research Community Forum webpage.

Job Opportunities

Do you appreciate a well-composed IRB submission? Can you navigate IRBNet with your ears closed? Is your reading comprehension sharp enough that you caught the mistake in the last sentence? If you answered yes to these questions, come join us at the IRB! IRB Administration will be recruiting several Research Compliance Analyst positions in the near future. We will send out another email with the link to these job listings once posted.

Submission Turnaround Time

Due to staffing vacancies, we are experiencing greater turnaround times than usual. Please plan ahead as there may be delays in turnaround times.

UC BRAID Guidelines and Best Practices for Multisite Participant Recruitment Using EMR

Multisite participant recruitment using EMR-derived cohorts requires special planning and consideration due to complexities around patient privacy, data limitations and security, and variance in local administrative practices. University of California Biomedical Research Acceleration, Integration, & Development (UC BRAID) has created guidelines and best practices intended to aid researchers in creating a multisite EMR recruitment plan that is respectful to patients, minimizes the risk of loss of patient confidentiality, and helps researchers anticipate and prepare for patient feedback. To view the Guidelines and Best Practices, please visit the BRAID Patient Recruitment webpage.

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May 9, 2022

In this edition

• Training Corner
• 2022 Research Expo
• Co-PI Policy for Greater Than Minimal Risk Biomedical Trials
• CITI Website Update

Training Corner

Self-Guided Trainings of the Month

Please look out for future emails with more information about signing up for the following trainings:

• Somebody Said I Need a Reliance, What Do I Do? Reliance Studies When UC Davis IRB Cedes Review
  Click HERE for a link to the video recording.

• Is IRB Review Required?
  Click HERE for a link to this self-guided training.

2022 Research Expo

The annual UC Davis Research Expo is being held this Wednesday, May 11. The UC Davis Research Expo is a one-day event that showcases the latest research-related insight, resources, opportunities, and tools to help you advance your research. For more information, including a link to registration, please see the Office of Research webpage for this event.

Co-PI Policy for Greater Than Minimal Risk Biomedical Trials

As a reminder, a Co-Principal Investigator is NOT required for any human subjects research conducted at UC Davis, including biomedical trials involving greater than minimal risk.

However, for biomedical trials involving greater than minimal risk, Principal Investigators must ensure that a responsible person is available to provide medical care to research participants whenever the Principal Investigator is unavailable to provide said care. This responsible person must:

• Be included on the Initial Review Application,
• Have sufficient medical training to oversee the medical care of participants, and
• Have sufficient training on the protocol requirements to avoid deviations from the protocol requirements unless the deviation is necessary to prevent imminent harm to participants.

For more information about training and coverage requirements for investigators conducting clinical trials and clinical investigations, please see HRP-093.

CITI Website Update

You may have noticed that the CITI training website has gotten a new look. The requirements for investigators and staff engaged in human subjects research, however, remain the same. To meet the basic human research protections training requirement, investigators and staff should complete whichever of the following trainings applies to the majority of their research:

• CITI Basic Course for Biomedical Researchers and Staff; or
• CITI Basic Course for Social and Behavioral Researchers and Staff

Do NOT complete the Responsible Conduct of Research trainings with similar names!

In addition to one of the trainings above, investigators and staff engaged in a clinical investigation or an NIH-funded clinical trial are required to take Good Clinical Practice (GCP) training.

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April 11, 2022

In this edition

• Update to COVID-19 IRB Review Policy
• Training Corner
• 2022 Research Expo
• IRB Forms Page Update

Update to COVID-19 IRB Review Policy

For the past two years, the UC Davis IRB has been prioritizing review of studies related to COVID-19 in order to support COVID-19 research efforts at our institution. At this time, we will no longer automatically be prioritizing review of research related to COVID-19. Researchers can still request a rush review if there are specific need. If you have any questions about this process change, please reach out to us at [email protected].

Training Corner

Upcoming Trainings

Please look out for future emails with more information about signing up for the following trainings:

• Somebody Said I Need a Reliance, What Do I Do? Reliance Studies When UC Davis is the IRB of Record
  Thursday, April 21 from 2:00 to 3:30 PM

• Where the Rubber Meets the Road: Requirements for Obtaining and Documenting Consent Every Researcher Should Know
  Thursday, April 28 from 2:00 to 3:30 PM

2022 Research Expo

The annual UC Davis Research Expo is being held on Wednesday, May 11. The UC Davis Research Expo is a one-day event that showcases the latest research-related insight, resources, opportunities and tools to help you advance your research. The event includes exhibits, presentations, workshops and opportunities to network with potential collaborators. You are welcome to enjoy the full event or attend portions that are of particular interest.

For more information, including a link to registration, please see the Office of Research webpage for this event.

IRB Forms Page Update

The IRB Forms page ​update is live. The new IRB Forms page has been designed to make it easier for researchers to find the forms and templates used in the conduct of human subjects research.

Please email [email protected] if you would like to test our new page and provide feedback. We need your feedback in order to make the IRB Administration website as useful to researchers as possible.

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March 4, 2022

In this edition

• Submission “Cheat Sheets”
• Training Corner
• Contraception Risk Language Reminder
• Request for IRB Forms Webpage Feedback
• Twenty-First Century Cures Act Language Reminder

Submission “Cheat Sheets”

On our New Projects page, the IRB Administration has released two new “cheat sheets” for the following research designs:

• UCDH chart review example submission
• Survey

The “cheat sheets” include completed Initial Review Applications, HRP-503 protocols, and HRP-502 consent documents (if applicable) for example studies. Each “cheat sheet” also incorporates tips for avoiding common mistakes and maintaining consistency between documents.

Training Corner

Upcoming Trainings

Please look out for future emails with more information about signing up for the following trainings:

• Somebody Said I Need a Reliance, What Do I Do? Reliance Studies When UC Davis is the IRB of Record
  Thursday, April 21 from 2:00 to 3:30 PM

• Where the Rubber Meets the Road: Requirements for Obtaining and Documenting Consent Every Researcher Should Know
  Thursday, April 28 from 2:00 to 3:30 PM

Self-Guided eLearning Modules of the Month

Are you a new researcher? Check out some of the self-guided trainings. This month we’re highlighting the following trainings:

• Is IRB Review Required?
• Initial Review Application Guide

Contraception Risk Language Reminder

As a reminder, UC Davis is leading the nation in the implementation of more inclusive consent language for non-binary, genderqueer, and transgender individuals. We highly recommend that you update this language when feasible. As a part of this effort, IRB Administration is developing a letter to be sent to sponsors along with proposed research changes. Keep an eye out for this new resource in April 2022.

Request for IRB Forms Webpage Feedback

The IRB Forms page is getting a makeover on March 7! The new IRB Forms page has been designed to make it easier for researchers to find the forms and templates used in the conduct of human subjects research.

Please email [email protected] if you would like to test our new page and provide feedback. We need your feedback in order to make the IRB Administration website as useful to researchers as possible.

Twenty-First Century Cures Act Language Reminder

For any study that requires research procedures or visits to be documented in the EMR per UCDH P&P 2317, please do not forget to add the Twenty-First Century Cures Act language at Continuing Review if these research procedures or visits are still ongoing. A consent addendum may also be used to communicate this information to subjects.

The Twenty-First Century Cures Act Language to be added is:

If you agree to participate in this research study, a signed copy of this consent document and the privacy authorization form may be filed in your electronic medical record (EMR) and your study participation may be added to your EMR. This information will be used for your care and treatment and for healthcare operations, which may include billing and payment. Federal and state privacy laws give patients the right to access information about their care and treatment contained in their medical record. During this study, you may not be able to access certain information related to this study in your EMR until the study is complete to ensure that the study remains unbiased. By consenting to participate in this study, you are also consenting to this possible temporary withholding of your research records.

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February 4, 2022

In this edition

• Submission turnaround time
• Updated forms and templates
• New contraception risk language reminder
• Request for New Project webpage feedback
• Personnel updates

Submission turnaround time

The IRB received more submissions in the month of January than we have received in the last three years! Please plan ahead as there may be delays in submission turnaround time as we tackle the high volume of submissions with a short staff.

Updated forms and templates

The HRP-503 General Template has been updated to include a Background section. This section ​had been omitted by mistake in the last update to this template.

The HRP-503 UCD Health Medical Record Review Template has been updated to define Protected Health Information (PHI) and will now include ​a section where submitters will check any of the 18 HIPAA identifiers they may be documenting in research records.

New contraception risk language reminder

As a reminder, the contraception risk language has been updated to be more inclusive for non-binary, genderqueer, and transgender individuals.

While researchers are not required to update the contraception risk language for studies that have already been approved, we do highly recommend that you update this language ​when feasible.

Request for New Project webpage feedback

The New Projects page ​is getting a makeover on Monday, February 4! IRB ​Administration has been hard at work to transform this page into a step-by-step checklist of everything required to submit a New Project to the IRB and is looking for feedback.​

Please email [email protected] if you would like to test our new page and provide feedback. We need your feedback in order to make the IRB Administration website as useful to researchers as possible.

Personnel updates

Mihaela Harris, the IRB’s longest-standing analyst, retired on January 31. This is what she had to say about her time at UC Davis:

During the course of 36 years at UC Davis, including 21 years at the IRB, I was privileged to be a part of the advancements our research community has accomplished.  Our IRB work has evolved in tremendous ways throughout the years, always with the focus on the subjects’ wellbeing, while improving our processes to help the researchers.  I leave with fond memories of the excellent work we did together.

We are happy to announce Nicole Walters as the new IRB Administration Associate Director. With over a decade of experience with the UC Davis IRB and a wealth of knowledge concerning everything human subjects research, we are excited to welcome Nicole in this new position.

We would also like to welcome Joseph Harrington to the IRB Administration staff. Joseph joins our team as an intake analyst, so look out for his IRBNet messages about any requested administrative changes to your submissions!

For the month of February, please correspond with Laura Jones for any items related to Committee B.

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November 2, 2021

In this edition

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September 29, 2021

In this edition

• Updated HRP-503 Protocol Templates
• Upcoming Training Events
• Employment Opportunity: IRB Analyst
• Follow Us on Twitter

Updated Protocol Templates

All versions of the HRP-503 Protocol Template have been updated to improve consistency and remove redundant questions. HRP-503 Protocol Templates can be found on the IRB Forms page or within the IRBNet Document Library. For your convenience, the links to each template are provided below. In addition, for assistance with selecting the appropriate template for a new project, IRB Administration has developed the attached HRP-503 Protocol Template Decision Tree. This new resource will soon be available on our website.

• HRP-503 General Template
• HRP-503 Record/Data/Specimen Secondary Analysis Review Template
• HRP-503 UCD Health Medical Record Review Template
• HRP-503 Surveys/Interviews and/or Focus Groups Review Template

Upcoming Training Events

Instructor Lead Training: In case you missed it: An overview of recent changes at the IRB (REG260) 

When: Tuesday, October 5 @ 2 pm

Where: Zoom

Registration: uc.sumtotal.host…

Presented by: CTSC Clinical Research Education Program

Description: IRB representatives will highlight recent changes and new resources available to researchers.

Topics include

• Updated Initial Review Application
• Post Approval Submission Form
• Signature requirements
• Definitions of Reportable Events and Minor Deviations
• Updates to HRP-503 Protocol Templates

Instructor Lead Training: Someone said I need a reliance, what do I do? The Reliance Process when UC Davis Cedes Review (REG160) 

When: Thursday, November 4 @ 2 pm

Where: Zoom

Registration:  uc.sumtotal.host…

Presented by: CTSC Clinical Research Education Program

Description: IRB representatives will discuss the reliance process and submission requirements when UC Davis relies on an external IRB.

Topics include

• Reliance terminology
• How to start a new reliance study
• Post-approvals submission requirements

Drop-in Office Hours hosted by the CTSC 

1st Fridays – Compliance: Research Billing and Privacy
2nd Fridays – Regulatory Overview & IRB Requirements
3rd Fridays – EMR Research Application
4th Fridays – REDCAP Database Management3rd Tuesdays- Study Pages- Clinical Trials Recruitment

Time: 12:00-2:00 pm

Where: Zoom
Registration: Not required

Additional Information: https://health.ucdavis.edu/ctsc/eventcalendar/index.html

Employment Opportunity: IRB Analyst

The IRB Support Analyst, IRB Committee and IRB Education Analyst position has posted for recruitment.

Brief Description:

Under supervision provide analytical support to the IRB Committee including coordinating IRB meetings, supporting educational activities, ensuring information on IRB Administration’s website is current, and maintaining IRB Administration’s document control.

For Full Consideration Apply By: 10/11/2021

Requisition Number:  24503

Payroll Title:  RSCH CMPLNC ANL 1

Position Number: 02023207

Department: IRB ADMINISTRATION – 061811

Salary Range: $19.54 – 39.27HR.

Quick Link To This Position: https://careerspub.universityofcalifornia.edu/psp/ucdavis/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&JobOpeningId=24503&PostingSeq=1&SiteId=7&languageCd=ENG&FOCUS=Applicant

Please contact OR-HR at [email protected] if you have any questions or need additional information.

Follow us on Twitter

Follow @UCDavisIRB to keep up to date on current events in the Human Research Protection Program at UC Davis. This account we be used to announce policy changes, document revisions, upcoming training, and new resources. The feed is also available on IRB Administration’s For Researchers page.

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August 30, 2021

In this edition

• Protocol Templates
  • NEW: HRP-503 UCD Health Medical Record Review Template
  • Coming Soon: Protocol Template Updates
• Revised
  • HRP-502 Consent Templates
  • New Projects Guidance – Required Signatures
  • Ancillary Reviews Guidance
• Reminders
  • Initial Review Application
  • HRP-210: Request for Determination
• Follow us on Twitter

Protocol Templates

NEW HRP-503 UCD Health Medical Record Review Template

To streamline the application and review process of medical chart review research, IRB Administration has developed a new Protocol Template. The HRP-503 UCD Health Medical Record Review Template can be used when research procedures are limited to secondary analysis of medical chart information from UCD Health Medical Records.

Coming Soon

To reduce administrative burden, IRB Administration is working to harmonize the HRP-503 Protocol Templates with the updated Initial Review Applications. As a part of this process the templates are being reviewed for consistency and clarity. New templates will be released later this year.

Revised

HRP-502 Consent Templates

HRP-502 Consent Template – Exempt Research and HRP-502 Consent Template – Survey/Interview Research have been updated with risk language to be international research. Additionally, Certificate of Confidentiality language has been added to HRP-502 Consent Template – Survey/Interview Research to be included as needed.

New Projects – Required Signatures Guidance

Guidance has been added to IRB Administration’s New Projects page to outline signature requirements for Initial Review of a New Project. All New Projects require Administrative Approvals. Previously, HRP-226 Administrative Approvals documented the required signatures and administrative attestations. With the recent update to the Initial Review Application, HRP-226 FORM is no longer required. The required signature and attestation information has been added to the website to ensure this information is easily accessible. It is also found within the Initial Review Application in IRBNet.

Ancillary Reviews Guidance

IRB Administration has updated our Ancillary Reviews guidance to align with changes made during the update of the Initial Review Application. The page has been restructured to display information based on IRB submission requirements.

Reminders

Initial Review Application

On June 1, 2021, the Initial Review Application update was released in IRBNet. For researchers who had an application prior to June 1, 2021, existing information will carry forward; however, new questions will require a response. The next time a change is made to the Application, please start from the General Instructions page, and advance one page at a time to ensure all fields are completed. This application is dynamic; if questions are left unanswered, pages may not display properly.

HRP-210: Request for Determination

All human subjects research projects require IRB review, regardless of funding. In some instances publishers, financial sponsors or others may require an documentation that a project is not human subjects research (NHSR). If you need an NHSR determination, submit HRP-210 FORM: Request for Determination. The purpose of completing the HRP-210 FORM is to provide the IRB with sufficient information about the activity to make an informed determination.

When completing the HRP-210 FORM:

• Please answer all the questions.
• Provide a brief description of the project objectives and procedures.
• Submit via IRBNet and select submission type “Other.”

Follow us on Twitter

Follow @UCDavisIRB to keep up to date on current events in the Human Research Protection Program at UC Davis. This account we be used to announce policy changes, document revisions, upcoming training, and new resources. The feed is also available on IRB Administration’s For Researchers page.

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June 24, 2021

In this edition:

New FDA Resources

The FDA recently released two new tools that were developed for investigators and clinicians: 1) Research IND Pilot Portal and 2) Expanded Access eRequest.

The Research IND (Investigational New Drug) Pilot Portal is a web-based tool for submission of non-eCTD (electronic Common Technical Document) Research INDs. The submission process is streamlined by using dynamic and intuitive questions with targeted links, resources, and CFR guidance. The tool provides user-friendly capabilities such as auto population of Form FDA 1571, reusable data, and a centralized dashboard to track all submissions. Digitizing non-eCTD Research IND submissions into an electronic, structured format will alleviate the amount of PDF/paper submissions FDA receives and thereby increase FDA review efficiency.

Expanded Access eRequest is a web-based tool that enables physicians to complete, sign, and submit non-emergency Expanded Access (EA) requests to FDA. EA eRequest helps physicians determine whether EA is appropriate for their patients, walks physicians through the process of completing Form FDA 3926, and provides useful links and resources. It is hosted by the Reagan-Udall Foundation for FDA and was developed with input from FDA.

See the announcement here: https://nexus.od.nih.gov/all/2021/06/04/new-fda-tools-for-investigators-and-clinicians/

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June 9, 2021

In this edition

• NEW
  • Administrative Modifications
  • Frequently Asked Questions Page
• UPDATES
  • HRP-001 Definitions
  • HRP-090 Informed Consent Process for Research and Adults Unable to Consent
• REMINDER: JUNE 1 CHANGES
  • New Initial Review Application
  • Post Approval Submission Form
  • Required Signatures on IRB Applications
• COMING SOON
  • Changes to Faculty Advisors

NEW!

Administrative Modifications 

“Administration Modification” is a new classification for changes to research that are so minor or benign they can be implemented without prior IRB approval.

In an effort to continue to reduce administrative burden in human subjects research while still ensuring that human subjects remain protected, the UC Davis IRB has developed this new category of modifications. For researchers who are familiar with Exempt research, this is simply the continuation of what the IRB has always indicated on its determination letters; that changes which do not alter the Exempt determination do not need to be submitted to the IRB. For researchers with IRB approved human subjects research, this is a new flexibility that will allow some very minor changes to be enacted without having to wait for IRB review (e.g., correction of typos, changes in contact information, etc.).

Due to the differences between Exempt research and research that requires IRB approval,  we have developed separate guidance and examples for each type on our website. Please visit our website here for Exempt research and here for approved research. Our examples are not meant to be all inclusive so if you think you have a change which should be considered an administrative modification but isn’t listed on our website, write to us at [email protected] and we can confirm whether it qualifies. We expect that there are many examples that researchers will bring to us and will update our website periodically with new examples as they are brought to us.

If an application is submitted to the IRB that contains only changes to research that qualify to be an administrative modification, the Amendment/Modification submission will go through an administrative review and the action taken for the application will be “Acknowledged”. The research will continue to be approved or Exempt based on the most recent IRB determination for the project.

 What if I already submitted a modification to the IRB but it’s listed on the website as an administrative modification?

The submission will be processed by IRB Administration in the order it was received. Because  Administrative Modifications do not require IRB approval, the determination for the application will be “Acknowledged.” If the changes submitted match the IRB’s guidance on what qualifies as an Administrative Modification, you may implement the change without waiting for IRB processing of the application.

What if my Sponsor says I have to submit a change to the IRB, but it’s clearly listed as an administrative modification on the IRB website?

Provide the study Sponsor with HRP-001 and HRP-021 as well as a link to the guidance on our website to explain that submission is not necessary. If they still insist that it be submitted, please note that   you believe the changes meet the definition of  an administrative modification and they are  being submitted at the request of the Sponsor in the Modification Description field of the Post Approval Submission Form. This will help our screeners move through these and acknowledge them more quickly. 

What if the change affects my stamped consent document? Do I need to submit to the IRB for a new stamp?

There is no requirement that a stamped version of the consent document be used. The only requirement is that the consent form used be the same version approved by the IRB +/- any administrative modifications. That said, we understand that researchers like to have their most current version of the ICF stamped for ease in making sure the most current version is used. If a new stamp is desired, submit a modification as normal and note   that this is an administrative modification to get a new stamped document in the Modification Description field of the Post Approval Submission Form. The person processing the modification will be able to acknowledge the administrative modification and provide you with a new stamped ICF.

Frequently Asked Questions Page

Have an IRB question but unsure where to start looking for answers? Check out the new IRB Administration Frequently Asked Questions page! Here you will find a list of the most common questions received at IRB Administration, along with brief answers and links to helpful resources. The list will be updated periodically with new content. If you have suggestions for new topics, send them to the IRB Education Team! We’ll assess the suggestion and continue building our library of information.

DOCUMENT UPDATES

HRP-001 Definitions

The definitions of the terms “minor deviation” and “non-compliance” have been updated to provide clarification about reporting requirements.

Minor Deviations: A change to, or non-compliance with, the research protocol that does not pose a risk of harm to the subject’s rights, safety or welfare, or to the integrity of the research data. Minor Deviations may result from the action or inaction of the participant, researcher, or research staff.

Non-Compliance: A failure to comply with the requirements of an applicable law, regulation, or institutional policy pertaining to the protection of human subjects, or with the requirements or determinations of an IRB that poses a risk of harm to subject’s rights, safety or welfare, or the integrity of the research data. Non-compliance may be the result of the action or inaction of anyone conducting protocol procedures, but not research subjects.

The intention behind these changes is to convey that minor deviations are things which are so minor that there’s never the possibility that a subject’s safety, welfare, or rights or the integrity of the data could be harmed. This contrasts with the previous definition which focused more on the outcome (e.g., was a subject harmed as a result of the event?) and not the possibility of harm (e.g., could a subject have been harmed as a result of the event?). The IRB’s guidance  on this subject has also been updated to clarify this distinction.

Why do I need to report an event to the IRB if the subject and data weren’t harmed?

A part of the IRB’s responsibility is that risks to subjects are identified and mitigated as best as possible. If new risks arise during the course of a study, the IRB is responsible to make sure those new risks are mitigated and subjects are informed if necessary. In order to ensure that the IRB continues to have a clear picture of the risks of a given study, it’s necessary for us to get these reports even when a subject isn’t harmed so that we can make sure appropriate mitigation steps are taken so that a subject isn’t harmed in the future.

A loss of data integrity also poses a problem because the risk/benefit assessment in any study is predicated on the idea that there will be some benefit to society (if not directly to the subject themselves) as a part of the research. The IRB is responsible for making a determination that the risks to subjects are reasonable in relation to the benefits of the overall study. If that benefit is removed due to a loss of data integrity, the study may fail to meet the criteria for approval as subjects could have been put at risk (even a minor one) for no purpose. Thus, we want to make sure we catch any problems with data integrity before they end up negating any findings of the study.

HRP-090: Informed Consent Process for Research and Adults Unable to Consent

The following requirement has been added to HRP-090: 3.4.4 Subjects who are adults unable to consent will be withdrawn if they appear to be unduly distressed. The IRB has long required that PIs attest that when they enroll adult subjects who are unable to consent for themselves that these subjects will be withdrawn if they appear unduly distressed. Unfortunately, this was often a requirement which wasn’t well captured in protocols or the Initial Review Application and was a subject of frequent revision requests. To combat this, the IRB has incorporated this requirement as a part of HRP-090 in Section 3.4. This way when the Initial Review Application is signed by the PI they are attesting that they will follow this process when they enroll adults who are unable to consent for themselves thus reducing possible revision requests and extra work for PIs and their staff.

REMINDER: JUNE 1 CHANGES

Initial Review Application

The UC Davis Initial Review Application update will reduce administrative burden for researchers by eliminating several of the free text response fields and providing new standardized answers in the form of checkboxes. The updated application will be released June 1. The impacts of this change are described below.

• Active research – No action required at the time. The next time you submit an application that includes revisions to the Initial Review Application, the form will lead you through any required fields
• Projects under review – To complete IRB review using the current Initial Review Application, you must make all requested changes prior to June 1, 2021. If you make any changes to the Initial Review Application after June 1, 2021, the application will automatically update the new version. Once updated, there is no way to revert to the past version of the application. If the IRB requires changes to your application after June 1, you will be required to update to the new application
• Works in Progress – If your project will be submitted after June 1, 2021, we highly recommend using the updated Initial Review Application. Once you have started the Initial Review Application, simply click the Initial Review Application pencil icon on the Designer page any time after June 1, 2021, to transition to the updated Initial Review Application. The form will lead you through any required fields.

IRB Administration has developed resources to support the transition to the updated Initial Review Application

• Researcher’s Guide to the Initial Review Application Update (PDF)
• IRBNet Demonstration Video: Initial Review Application Update (runtime ~30 mins)

Post Approval Submission Form 

All post approval submissions will require the Post Approval Submission Form. The following forms will no longer be accepted:

• HRP-212 Continuing Review Progress Report
• HRP-212 Continuing Review Relying sIRB Site
• HRP-213 Modification
• HRP-214 Reportable New Information

IRB Administration has developed resources to support the transition to the Post Approval Submission Form.

• Transitioning to the Post Approval Submission Form (PDF)
• IRBNet Demonstration Video: Post Approval Submissions (video, ~20 mins)
• Post Approval Submissions (eLearning)

Signatures on IRB Applications

Effective June 1, all signatures on applications to the IRB must be completed using IRBNet’s “Sign this Package” feature. To support this transition, detailed instructions, video tutorials, and Quick Reference Guides can be found below. In addition, IRB Administration is now posting a list of all UC Davis IRBNet Registered Users on our IRBNet Guidance page. This list can be used to confirm if a UC Davis affiliate has an active IRBNet account. Visit the IRBNet Guidance page for additional information.

• UC Davis Demonstration Video: Adding Your Electronic Signature in IRBNet (1 min, 50 sec)
• Adding your Electronic Signature (PDF)
• Electronic Signature Quick Reference Sheet (PDF)
• IRBNet Registered User Report (PDF)

COMING SOON! Changes to Faculty Advisors

Effective July 1, 2021, changes to Faculty Advisors must be approved by the IRB prior to implementation. The Faculty Advisor, when required, is responsible for ensuring research is conducted as described in the research protocol and in compliance with all requirements. The IRB has long held the policy that a  modification is not required to update the research personnel list for a study unless the change is to the PI or Co-PI.  Given that the duties of a Faculty Advisor  are similar to that of a PI or Co-PI, it is appropriate that these changes be submitted to the IRB. As such, effective July 1, 2021, the IRB will require a modification to document changes to the  PI, Co-PI, or Faculty Advisor prior to implementation.

What if we already changed the Faculty Advisor but didn’t submit it to the IRB yet? Will I need to submit a modification and/or RNI?

Please prepare and submit a modification to the IRB ASAP so that we can have the correct Faculty Advisor on file. An RNI will not be necessary if the change occurred prior to July 1^st, 2021.

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May 28, 2021

In this edition

• New Resources
• Reminder: Changes take Effect June 1
  • Initial Review Application Update
  • Post Approval Submission Form
  • IRBNet Signatures
• Follow @UCDavisIRB on Twitter

New IRA Update Resources

Changes to the IRB’s Initial Review Application (IRA) take effect June 1, 2021. To assist with the transition, IRB Administration has developed the attached Researcher’s Guide to the Initial Review Application Update. The guide contains an overview of the substantial changes to the application along with side-by-side comparison of each page of the application containing highlighted edits. Pages are bookmarked to allow easy navigation to a topic of interest.

In addition, a new IRBNet Demonstration Video: Initial Review Application Update is now available (runtime ~30 mins). The video walks a submitter through the updated Initial Review Application and highlights some important changes.

Reminder: Changes Take Effect June 1, 2021

New Projects

The UC Davis Initial Review Application update will reduce administrative burden for researchers by eliminating several of the free text response fields and providing new standardized answers in the form of checkboxes. The updated application will be released June 1. The impacts of this change are described below.

• Active research – No action required at the time. The next time you submit an application that includes revisions to the Initial Review Application, the form will lead you through any required fields
• Projects under review – To complete IRB review using the current Initial Review Application, you must make all requested changes prior to June 1, 2021. If you make any changes to the Initial Review Application after June 1, 2021, the application will automatically update the new version. Once updated, there is no way to revert to the past version of the application. If the IRB requires changes to your application after June 1, you will be required to update to the new application
• Works in Progress – If your project will be submitted after June 1, 2021, we highly recommend using the updated Initial Review Application. Once you have started the Initial Review Application, simply click the Initial Review Application pencil icon on the Designer page any time after June 1, 2021, to transition to the updated Initial Review Application. The form will lead you through any required fields.

Post Approval Submissions

All post approval submissions will require the Post Approval Submission Form. The following forms will no longer be accepted:

• HRP-212 Continuing Review Progress Report
• HRP-212 Continuing Review Relying sIRB Site
• HRP-213 Modification
• HRP-214 Reportable New Information

IRB Administration has developed resources to support the transition to the Post Approval Submission Form.

• Transitioning to the Post Approval Submission Form (PDF)
• IRBNet Demonstration Video: Post Approval Submissions (video, ~20 mins)
• Post Approval Submissions (eLearning)

Signatures on IRB Applications

Effective June 1, all signatures on applications to the IRB must be completed using IRBNet’s “Sign this Package” feature. To support this transition, detailed instructions, video tutorials, and Quick Reference Guides can be found below. In addition, IRB Administration is now posting a list of all UC Davis IRBNet Registered Users on our IRBNet Guidance page. This list can be used to confirm if a UC Davis affiliate has an active IRBNet account. Visit the IRBNet Guidance page for additional information.

• UC Davis Demonstration Video: Adding Your Electronic Signature in IRBNet (1 min, 50 sec)
• Adding your Electronic Signature (PDF)
• Electronic Signature Quick Reference Sheet (PDF)
• IRBNet Registered User Report (PDF)

Related Resources

• UC Davis Demonstration Video: How do I share project access with other personnel?
• UC Davis Demonstration Video: Using Tags in IRBNet

Follow us on Twitter

Follow @UCDavisIRB to keep up to date on current events in the Human Research Protection Program at UC Davis. This account we be used to announce policy changes, document revisions, upcoming training, and new resources. The feed is also available on IRB Administration’s For Researchers page.

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May 24, 2021

In this edition

• New Projects
• Post Approval Submissions
• IRBNet Signatures

The following changes take effect June 1, 2021.

New Projects

The UC Davis Initial Review Application update will reduce administrative burden for researchers by eliminating several of the free text response fields and providing new standardized answers in the form of checkboxes. The updated application will be released June 1. The impacts of this change are described below.

• Active research – No action required at the time. The next time you submit an application that includes revisions to the Initial Review Application, the form will lead you through any required fields
• Projects under review – To complete IRB review using the current Initial Review Application, you must make all requested changes prior to June 1, 2021. If you make any changes to the Initial Review Application after June 1, 2021, the application will automatically update the new version. Once updated, there is no way to revert to the past version of the application. If the IRB requires changes to your application after June 1, you will be required to update to the new application
• Works in Progress – If your project will be submitted after June 1, 2021, we highly recommend using the updated Initial Review Application. Once you have started the Initial Review Application, simply click the Initial Review Application pencil icon on the Designer page any time after June 1, 2021, to transition to the updated Initial Review Application. The form will lead you through any required fields.

Post Approval Submissions

All post approval submissions will require the Post Approval Submission Form. The following forms will no longer be accepted:

• HRP-212 Continuing Review Progress Report
• HRP-212 Continuing Review Relying sIRB Site
• HRP-213 Modification
• HRP-214 Reportable New Information

IRB Administration has developed resources to support the transition to the Post Approval Submission Form.

• Transitioning to the Post Approval Submission Form (PDF)
• IRBNet Demonstration Video: Post Approval Submissions (video, ~20 mins)
• Post Approval Submissions (eLearning)

Signatures on IRB Applications

Effective June 1, all signatures on applications to the IRB must be completed using IRBNet’s “Sign this Package” feature. To support this transition, detailed instructions, video tutorials, and Quick Reference Guides can be found below. In addition, IRB Administration is now posting a list of all UC Davis IRBNet Registered Users on our IRBNet Guidance page. This list can be used to confirm if a UC Davis affiliate has an active IRBNet account. Visit the IRBNet Guidance page for additional information.

• UC Davis Demonstration Video: Adding Your Electronic Signature in IRBNet (1 min, 50 sec)
• Adding your Electronic Signature (PDF)
• Electronic Signature Quick Reference Sheet (PDF)
• IRBNet Registered User Report (PDF)

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May 04, 2021

In this edition

• Upcoming Application Changes
• IRBNet Signatures
• Reminder: IRB Reliance Fees

Upcoming Application Changes

During this week’s UC Davis Research Administration Forum, information was presented about upcoming changes to IRB applications. A recording of the presentation is now available. Please share with your colleagues who submit to the IRB.  (video, runtime: ~15 mins)

In preparation for the upcoming changes to IRB applications, the following forms will be removed from the IRB website and IRBNet Document Library this week:

• HRP-212 Continuing Review Progress Report
• HRP-212 Continuing Review Relying sIRB Site
• HRP-213 Modification
• HRP-214 Reportable New Information

To help with the transition to the Post Approval Submission Form, a video recording of the recent Post Approval Submission Training is now available. View the entire video for a comprehensive look at all types of post approval submissions or jump ahead to the IRBNet demonstration to learn how to use the Post Approval Submission Form to submit to the IRB.

IRBNet Signatures

Effective June 1, all signatures on applications to the IRB must be completed using IRBNet’s “Sign this Package” feature. To support this transition, detailed instructions, video tutorials, and Quick Reference Guides can be found below. In addition, IRB Administration is now posting a list of all UC Davis IRBNet Registered Users on our IRBNet Guidance page. This list can be used to confirm if a UC Davis affiliated has an active IRBNet account. Visit the IRBNet Guidance page for additional information.

• UC Davis Demonstration Video: Adding Your Electronic Signature in IRBNet (1 min, 50 sec)
• Adding your Electronic Signature (PDF)
• Electronic Signature Quick Reference Sheet (PDF)
• IRBNet Registered User Report (PDF)

Step-by-Step Instructions

1. Enter your username and password at irbnet.org
2. Use the search tools to locate the project, click the project title to open the package
3. Review study details and documents
4. From the left-hand menu select “Sign this Package”
5. Use the dropdown list to select the appropriate role and click “Sign”
6. Principal Investigator – Principal Investigator
7. Department Chair – Department Head
8. Faculty Advisor – Advisor
9. Dean – Other Signatory

Notes:

• If you have previously signed the package, IRBNet will ask if you wish to sign it again. If you need to re-sign the package, click “OK.”
• UC Davis IRB does not accept signatures completed using the Designee Signature mode.

Reminder: IRB Reliance Fees

In January 2021, IRB announced changes to the IRB Reliance Fee structure. The changes apply to both industry funded and non-industry funded studies. Review the January 7th announcement and Reliance Fee Form for details.

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Office of Research Community Form – April 28, 2021

Overview of new learning resources and upcoming changes to IRB applications and signature process.

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April 14, 2021

In this edition:

• Changes to IRB Letterhead
• Reminder: IRB Application Updates
• Reminder: New Electronic Signature Requirements
• Upcoming Training Events

Changes to IRB Letterhead

As UC Davis goes through the rebranding process, the letterhead that the UC Davis IRB has been using with the UC Davis seal has been restricted to use by only the Chancellor’s Office. As such, the Office of Research has provided the IRB with new letterhead to use moving forward. The new letterhead that will be present on IRB determination and approval letters moving forward will incorporate the Office of Research’s Unit Signature with the words “UC Davis” in gold above the words “Office of Research” in blue beneath them. The rest of the content of the letters will remain unchanged. For more information about branding changes, please see the Brand Communications Guide. For examples of the various UC Davis seals, wordmarks, and unit signatures, please see the Logos page of the Brand Guide website.

When will we see the new letterhead?

The new letterhead is effective immediately and you may have already received an approval or determination letter with the new letterhead.

What do I tell a Sponsor who has questions about the new letterhead?

Please feel free to provide them with a copy of this announcement and direct them to the logos page and brand guide linked above showing that the UC Davis seal is now a restricted letterhead.

IRB Application Updates

Changes are coming to the IRB application forms! This Spring the IRB will transition to electronic data capture for applications and electronic signatures on all forms.

Initial Review Application (IRA)

The IRA is being revised to streamline the submission process, improve data capture, and reduce administrative burden. Training materials are currently being developed and will be available for use when the updated IRA is released.

Post Approval Submissions Form (PASF)

Effective June 1, 2021, the IRB will require the PASF for all post approval submissions. The PASF is live in IRBNet and available for use now! To support this process, IRB Administration has created the following resources:

Transitioning to the Post Approval Submission Form (PDF)

Post Approval Submissions (eLearning)

IRBNet Electronic Signatures (video)

Adding Your Electronic Signature (PDF)

Electronic Signature Requirements

Effective June 1, 2021, IRBNet electronic signatures will be required for all applications. We encourage all signatories to start using the IRBNet signature feature now by following the simple steps in the guide Adding Your Electronic Signature or following the instructions in this brief training video IRBNet Electronic Signatures.

Reminder: All users must register with IRBNet before they can be granted access to a project. The research team must share the project before the signatory can access the project in IRBNet. Detailed instructions for IRBNet registration and sharing of projects can be found on the IRBNet Guidance page.

Upcoming Training Events

CTSC: IRB Reporting Requirements: Minor Deviations and Reportable Events REG 230

Date: April 22, 2021

Time: 9am-10am

Location: Zoom

Registration: Register at LMS

*Zoom advance registration is required. Zoom registration link will be sent after LMS registration is completed.

CTSC: IRB – Post Approval Submissions REG 180

Date: April 27, 2021

Time: 9am-10am

Location: Zoom

Registration: Register at LMS

*Zoom advance registration is required. Zoom registration link will be sent after LMS registration is completed.

Visit the IRB Training Library for online learning resources.

Contact the IRB Help Desk with questions or requests for assistance.

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April 2, 2021

In this edition:

• *New* eLearning Resources
• Upcoming Training Events
• IRB Application Updates
• Electronic Signature Requirements

*New* Self-guided eLearning Resources

IRB training courses are now available in an interactive, online format. The eLearning modules can be used to onboard new personnel, guide submitters through the application requirements, or enhance the knowledge of more experienced research personnel. The following modules are available now:

• UC Davis Human Research Protection Program Overview
• Is IRB Review Required?
• New Project Applications
• Initial Review Application Guide
• Post Approval Submissions
• Informed Consent Form Requirements
• Remote Consent for Research
• Outside Financial Interest Reporting in Human Research

More modules coming soon! You can find these and other training resources at the IRB Training Library.

Upcoming Training Events

CTSC: IRB Reporting Requirements: Minor Deviations and Reportable Events REG 230

Date: April 22, 2021

Time: 9am-10am

Location: Zoom

Registration: Register at LMS

*Zoom advance registration is required. Zoom registration link will be sent after LMS registration is completed.

CTSC: IRB – Post Approval Submissions REG 180

Date: April 27, 2021

Time: 9am-10am

Location: Zoom

Registration: Register at LMS

*Zoom advance registration is required. Zoom registration link will be sent after LMS registration is completed.

IRB Application Updates

Changes are coming to the IRB application forms! This Spring the IRB will transition to electronic data capture for applications and electronic signatures on all forms.

New Projects – Initial Review Application

The Initial Review Application (IRA) is getting a tune-up. When the new IRA is released, the transition will be seamless. Researchers will be directed to the updated IRA by following the standard application process. The IRA is being revised to streamline the submission process, improve data capture, and reduce administrative burden. Training materials are currently being developed and will be available for use when the updated IRA is released.

Highlights

• Questions updated to reflect changes in regulations and institutional policies.
• When possible, free text boxes converted into checkbox selections.
• HRP-226 attestation incorporated into the IRA to streamline application process. HRP-226 will no longer be a required document.
• Reliance Cover Sheet incorporated into the IRA to streamline application process. Cover Sheet will no longer be a required document.
• Language updated to allow non-UC Davis PIs to submit to UC Davis IRB under a reliance agreement.
• Redundant questions removed to reduce administrative burden.
• Ancillary approvals questions expanded to improve compliance.
• Explanatory text and definitions added throughout.

Post Approval Submissions Form

Effective June 1, 2021, the IRB will require the Post Approval Submission Form for all post approval submissions. The PASF can be used to submit Continuing Review/Progress Reports, Amendment/Modification, Other Reportable Events and Closure/Final Report or any combination of these submission types. The IRB’s website, SOPs and other materials are currently being updated to reflect this change. After June 1, the following paper forms will no longer be accepted:

•  FORM: HRP-212 CONTINUING REVIEW PROGRESS REPORT
•  FORM: MODIFICATION (HRP-213)
•  FORM: REPORTABLE NEW INFORMATION HRP-214

The Post Approval Submission Form is live in IRBNet, and available for use! Researchers are encouraged to start using the Post Approval Submission Form at the next opportunity. To support this process, IRB Administration has created the following resources:

• Transitioning to the Post Approval Submission Form (PDF)
• Post Approval Submissions (includes Post Approval Submission Form Guide!) (eLearning)
• Adding Your Electronic Signature (PDF)

 Electronic Signature Requirements

IRBNet electronic signatures have been accepted on all applications types for several years. Once the old “paper” forms are retired, there will no longer be signature lines to collect administrative approval and other required signatures. All signatures will be completed using the IRBNet “Sign this Package” feature. IRB Administration will provide training and learning resources to familiarize new users with the process. We encourage all signatories to start using the IRBNet signature feature now by following the simples steps in the guide: Adding Your Electronic Signature.

Reminder: All users must register with IRBNet before they can be granted access to a project. The research team must share the project before the signatory can access the project in IRBNet. Detailed instructions for IRBNet registration and sharing of projects can be found on the IRBNet Guidance page.

Contact the IRB Help Desk with questions or requests for assistance.

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March 17, 2020

CTSC: IRB – New Projects Submissions REG 170

 Date: March 23, 2021

 Time: 9am-10:30am

 Location: Zoom

 Cost: No cost

 Registration: Register at LMS

New Projects Submissions is a beginner level course designed for researchers and administrators who will submit New Project applications to the IRB. Those who complete all course materials will understand the role of the IRB, the types of projects that require IRB oversight, and how to apply for IRB review of a New Project.

This blended learning course is made up of two unique learning opportunities:

1. A series of self-guided eLearning lessons about the UC Davis Human Research Protection Program and IRB review. To get the most of out of this course, please review these lessons before attending the live session: 
2. UC Davis Human Research Protection Program Overview
3. Is IRB Review Required?
4. New Project Applications
5. Initial Review Application Guide
6. A live interactive training. During the live training, IRB administrators will demonstrate the process of creating and submitting a new project for IRB review. This course will employ several interactive learning activities, please be prepared to actively participate by ensuring you have access to a microphone and computer, if possible.

Zoom advance registration is required. Zoom registration link will be sent after LMS registration is completed.

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March 2, 2021

CTSC: ICF Fundamentals – Pt. 1: Developing Informed Consent Documents REG 130

Date: March 4, 2021

Time: 9am-10am

Location: Zoom

Cost: No cost

Registration: Register at LMS

In Part 1 of this interactive course, we will focus on developing the consent document. Representatives from IRB Administration will discuss the legal requirements of consent documents, highlight common problems, and provide practical tips to improve your application to the IRB. Attendees will review a consent document from the IRB’s perspective to determine if it meets the criteria for approval. We will also discuss options for developing consent documents when language barriers exist.

Zoom advance registration is required. Zoom registration information will be sent after LMS registration is completed.

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February 19, 2021

In this edition:

• Updated UCOP Surrogate Consent Guidance and Certification
• Reminder: HRP-091 Update

NEW: Updated UCOP Surrogate Consent Guidance and Certification

For researchers conducting studies with adult subjects who are cognitively impaired, UCOP had previously issued guidance and a certification form which could be used in this process to ensure compliance with state laws when using a surrogate or legally authorized representative (LAR) to obtain informed consent. The updated guidance touches on several important topics when utilizing this vulnerable population as subjects in a research study including: state criteria for use of a surrogate, information to be contained in the IRB application, how to assess the decision-making capacity of a subject, who can serve as a surrogate/LAR, and when re-consent should occur. The full text of the updated guidance can be found on UCOP’s website here.

To assist with appropriate record-keeping, UCOP has also updated the surrogate decision maker certification form. The new form no longer requires that the surrogate provide contact information to the researcher so long as the researcher has a method to contact the surrogate and no longer requires that the surrogate sign the form. The form now also has a section which allows researchers to document that all the criteria for use of a surrogate have been met. The new surrogate decision maker certification form can be found on UCOP’s website here.

My study is using the old certification form. Do I need to submit to the IRB to use the new form?

No, the updated form is the product of the UC IRB Directors and RPAC staff at UCOP working group. Since the form will not be seen or completed by subjects or their surrogates, separate approval from the IRB to use this new form is not necessary.

My protocol describes a different method for determining subject capacity than the tool in the UCOP guidance. Do I need to change my protocol?

No, if the study is currently approved, then the IRB has also approved whatever method is specified in the protocol for making a capacity decision. If the study is not yet approved or submitted, please be sure to explain in the protocol or application how subjects will be assessed for the capacity to make decisions.

REMINDER: Updated HRP-091

The IRB updated it’s SOP HRP-091 (Written Documentation of Consent) in August 2020 to revise the requirements for signatures when utilizing the short form process. Specifically, section 5.2.2.1 was updated to no longer require that the person obtaining consent, subject, and witness sign both the summary and the short form consent document. Now, the subject needs only sign the short form consent document, the person obtaining consent needs only sign the summary, and the witness signs both documents. Another way to remember this is that each person will only sign the document that they can personally read. This change was done to reduce burden on research personnel, provide better ethical protections for subjects, and more closely align with Federal regulations for consent.

What if I still followed the old process even after the new SOP was issued? Do I need to submit an RNI?

No. If the old process was followed, this goes above and beyond what is currently required and so an RNI is not necessary.

The short form documents still have a place for the person obtaining consent to sign. What should researchers do?

The IRB is working to update our website with new documents that don’t have this signature line. In the meantime, researchers can utilize a note to file as needed referencing the new HRP-091 SOP as an explanation.

The summary is usually just the study’s main consent document which has a place for the subject to sign. Do I need to submit a modification if I want to use the short form?

No. When the short form is used, a brief note can be placed in the research chart of the subject stating that the short form was used and so the English form wasn’t signed by the subject in keeping with HRP-091.

For additional questions pertaining to these topics not addressed in this announcement or for general inquiries, please contact the IRB Help Desk at [email protected] or during business hours (M-F 7 am – 4 pm) at 916-703-9158.

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January 7, 2021

In this edition:

• IRB Reliance Fee Changes
• Part 11 Compliant DocuSign Available for FDA Regulated Studies
• REMINDER: Updating Informed Consent Documents when Relying on an External IRB

IRB Reliance Fee Changes

Changes for non-Industry funded studies

The UC Davis IRB will continue to review non-Industry funded research studies on behalf of the UCD and UCDH campuses and UC ANR free of charge regardless of whether or not we serve as the IRB of Record or are asked to rely on an external IRB. When we are asked to serve as the IRB of Record for other institutions, the following fees will apply:

Institution Type	Initial Review	Continuing Review
UC Campus	$2,224	$1,211
Non-UC Institution	$2,974	$1,620

Changes for Industry Funded Studies

The UC Davis IRB will continue to charge $3400 for initial review and $1600 for continuing review when we review an industry funded study on behalf of the UCD or UCDH campuses or UC ANR. If we are asked to review for additional institutions, the fees described above will also apply for each additional site for which we are asked to review. If the UC Davis IRB is asked to rely on an outside IRB for the review of these studies, we will charge the following one-time fees for completing the required local context review:

Institution Type	Local Context Review
UC Campus	$2,500
Non-UC Institution	$3,343

When will these fees go into effect?

Non-Industry Funded Studies Where UC Davis Reviews for External Sites:

The current fee schedule will remain in effect for all studies which are funded by proposals whose submission deadline is on or before January 31, 2021. After that date, proposals which are funded will be charged according to the fee schedule above. If your RFP submission date is after January 31, 2021, please be sure to include the above costs in your proposal budget.

Industry Funded Studies Where UC Davis Reviews for External Sites:

The fees described above will be in effect for all studies or new reliance requests submitted on or after February 1, 2021.

Industry Funded Studies Where UC Davis Relies on an External IRB:

The fees described above are effective immediately as the IRB has been collecting fee forms and the above costs have been required in budgets since July 1, 2020. The above fees represent a decrease from our normal fee of $3400 that investigators were previously instructed to be budgeting for in proposals and contracts so there should be no deleterious effects on study budgets as a result.

What types of studies are subject to IRB fees?

For a complete description of applicability of fees and exceptions, please see above and the IRB’s fee webpage.

Why are these fees being changed?

When the single-IRB mandate was first introduced by the NIH and then later incorporated into human research regulations (i.e. the Common Rule), it was unknown what effect this change in the way IRBs are required to do business would have on costs associated with reviews. Now that we have real-world data on how this has changed our processes and what fair market value is, we have adjusted our fees accordingly. Please keep in mind that many reviews still do not incur a review fee and their review is subsidized by the University to facilitate ethical and compliant research.

What if I still have questions?

You may contact the IRB at any time with questions by writing to [email protected].

Part 11 Compliant DocuSign Available for FDA Regulated Studies

During the early days of the pandemic the IRB issued guidance in coordination with the University and Office of Research about the use of DocuSign for FDA regulated studies given that the available DocuSign accounts at that time were not Part 11 compliant. That guidance can be found on the Office of Research’s COVID-19 page here. A Part 11 DocuSign Module has been purchased for UCDH researchers and is being administered by IT Health Informatics. More information about DocuSign’s Part 11 module can be found on their webpage here.

I have an FDA regulated study and am interested in using DocuSign to obtain consent and HIPAA authorization. How do I get access?

UCDH users wanting to get access to the Part 11 DocuSign module will need to put in a request through the Service Now portal. On the “Request Service” page search for “DocuSign” and select “DocuSign Access”. Those seeking to gain access to the Part 11 module will need to state their need for the Part 11 module in the comments section of the request.

Do I need to have both a Part 11 and Regular DocuSign account? Can I just use the Part 11 account for all my studies?

Users of the Part 11 module should only use this module for their FDA regulated studies due to the limited availability of Part 11 “envelopes” in the DocuSign system. As such, users who have both FDA regulated and non-FDA regulated studies will need two DocuSign accounts.

I followed the IRB’s guidance and used the regular DocuSign to consent people for my FDA regulated study. Do I have to re-consent them?

Maybe. If the research team is still having interactions with the research subjects, they should be re-consented at their next study “visit” which may be held remotely. They can either be re-consented using the standard paper and pen method or through the new Part 11 DocuSign module. Any subject who has withdrawn or is no longer having interactions with the research team does not need to be re-consented.

I still have more questions. Who can I ask?

If there are questions about DocuSign Part 11 accounts or how to use the Part 11 module, please contact IT Health Informatics at 916-734-4357. If there are questions about Part 11 compliance for a study or other study related questions, please contact the IRB Help Desk at [email protected]

REMINDER: Updating Informed Consent Documents when Relying on an External IRB

If you have a study which is reviewed by an external IRB (E.g. WIRB, Advarra, etc.) it is important to remember to check new consent documents as they become available to ensure that they contain UC Davis IRB required language (found on our website here) as well as any language agreed to during the local context review by the UC Davis IRB Reliance Team. While the UC Davis IRB will ensure that consent documents meet all requirements at the time we cede review to an external IRB, it is the joint responsibility of the external IRB and UC Davis PI to ensure that any required and/or agreed upon language remains as written at the time the UC Davis IRB cedes its review. If during the course of a study required and/or agreed upon language is changed, the study may no longer meet all State, UC, and Local requirements. If you receive an updated consent document and have questions about whether it still meets State, UC, and Local requirements, please contact the UC Davis IRB Reliance Team at [email protected].

What kind of language should researchers be concerned about?

Typically, the external IRB will modify consent documents with updated risks, procedures, and number of subjects throughout the course of the study to keep documents in line with changes to the protocol which may be needed. These are not sections which researchers should be concerned about. Instead, we would ask researchers to focus on sections which describe what happens to the information and/or biospecimens collected for a study, any rights the subjects may have (e.g. experimental subject’s bill of rights, rights to access data during the study, etc.) and how to exercise such rights, what will happen in case of an injury to the subject, and conflict of interest language, if applicable.

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December 18, 2020

All administrative units in the Office of Research will be closed for business from 21 December to 3 January with only emergency support if necessary for the following offices:

 OFFICE/UNIT EMERGENCY CONTACT

• Sponsored Programs Office (SPO) 530-754-7700
• Institutional Review Board (IRB) 530-304-1226 or [email protected]
• Institutional Animal Care and Use Committee (IACUC) [email protected]
• Research Compliance & Integrity (RCI) [email protected]
• Research Core Facilities Program 530-754-1272 or [email protected]

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November 13, 2020

Holiday Closure

IRB Administration will be closed Monday December 21, 2020 through Friday, January 1, 2021. We will re-open Monday, January 4, 2021. You may experience longer than typical processing times for IRB applications. We appreciate your patience. Submissions which need to have review initiated prior to the end of the year must be submitted no later than November 19^th. For studies which require approval prior to January (e.g. funding deadline), please be sure to submit them by November 19^th and include in the submission a rush request and justification. For urgent situations, please call 530-304-1226 or email [email protected].

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October 20,2020

In this Edition:

• New Requirement: Consent Form Language
• Upcoming IRB Training: Post Approval Submission Form

New Requirement Consent Form Language

The IRB has added a few new sentences to our consent form templates that we wanted to point out to the research community and explain a little bit more about as the language may seem a bit odd. The new language we have added is:

Federal and state privacy laws give patients the right to access information about their care and treatment contained in their medical record. During this study, you may not be able to access certain information related to this study in your EMR until the study is complete to ensure that the study remains unbiased.  If it is necessary for your care, this information will be provided to you or your physician.

What studies need to have this language in their consent forms?

Any study that is required to be documented in the EMR per UCDH P&P 2317 and which is actively enrolling subjects.

My current study needs this new language, what do I do?

IRB analysts will be checking for this required language in new studies, modifications, and continuing reviews being submitted. If this language is required, your IRB analyst will let you know to add it. If you are preparing a new study, modification, or continuing review submission, make sure that the new language is included if appropriate. A separate modification is not required at this time.

 Why is this new language being implemented?

This language is being implemented as a result of the 21^st Century Cures Act which was signed into law by President Obama. This law requires that Electronic Health Information pertaining to a patient be provided to patients or be made available to third parties designated by a patient. There are some exceptions which allow research information to be blocked (either permanently or during the course of the study), but not all research information fits into these exceptions. This language is being added so that research data which may bias a study (e.g. un-blind the subject) can be withheld from the patient as appropriate.

Will the IRB’s consent form templates be updated with this new language? Where does this go in the consent form?

Yes, we have already updated the language in the consent form templates on our website where this language would be applicable. The new language will appear in the section “What happens to the information collected for the research?” on our general consent form templates and the “Confidentiality” section of our minimal risk specimen research template. We have inserted this language in the paragraph which describes that the consent form and HIPAA authorization will be uploaded into EMR to provide a natural discussion point when conducting the consent process.

IRB Upcoming Training – Post Approval Submissions

When: THURSDAY, OCTOBER 22, 2020, 9 – 10AM

Where: Zoom

Register: uc.sumtotal.host…

Designed for researchers new to human subjects research at UC Davis who submit post approval submissions to the IRB. Attendees will learn when and how to maintain IRB approval, what the IRB is looking for during the review process, and how to navigate our electronic submission system, IRBNet. During this interactive course we will focus on the process of post approval submissions, corresponding with the IRB, and securing approval documents to maintain compliance. Attendees should create an IRBNet account prior to attending class.

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September 14, 2020

The CTSC has announced the 20/21 Education Program. See attached flyer for details.

As part of the program, join representatives from IRB Administration for the following Fall classes:

• ICF Fundamentals  – Pt. 1: Developing Informed Consent Documents
• IRB Reporting Requirements: Minor Deviations and Reportable Events
• IRB – Post Approval Submissions

Classes are open to all UC Davis faculty, staff and students. Zoom advance registration is required. Zoom registration information will be sent after LMS registration is completed.

ICF Fundamentals – Pt. 1: Developing Informed Consent Documents

When: THURSDAY, SEPTEMBER 17, 2020, 9 – 10AM

Where: Zoom

Register: uc.sumtotal.host…

In Part 1 of this interactive course, we will focus on developing the consent document. Representatives from IRB Administration will discuss the legal requirements of consent documents, highlight common problems, and provide practical tips to improve your application to the IRB. Attendees will review a consent document from the IRB’s perspective to determine if it meets the criteria for approval. We will also discuss options for developing consent documents when language barriers exist.

IRB Reporting Requirements – Minor Deviations and Reportable Events

When: TUESDAY, OCTOBER 13, 2020, 9 – 10AM

Where: Zoom

Register: uc.sumtotal.host…

Designed for those who submit to the IRB, attendees will learn how to identify a reportable event, what to report to the IRB and a process for developing an effective Corrective and Preventative Action Plan (CAPA).

IRB – Post Approval Submissions

When: THURSDAY, OCTOBER 22, 2020, 9 – 10AM

Where: Zoom

Register: uc.sumtotal.host…

Designed for researchers new to human subjects research at UC Davis who submit post approval submissions to the IRB. Attendees will learn when and how to maintain IRB approval, what the IRB is looking for during the review process, and how to navigate our electronic submission system, IRBNet. During this interactive course we will focus on the process of post approval submissions, corresponding with the IRB, and securing approval documents to maintain compliance. Attendees should create an IRBNet account prior to attending class.

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September 9, 2020

The CTSC has announced the 20/21 Education Program. See attached flyer for details.

As part of the program, join representatives from IRB Administration for the following Fall classes:

• IRB – New Projects Submissions
• ICF Fundamentals  – Pt. 1: Developing Informed Consent Documents
• IRB Reporting Requirements: Minor Deviations and Reportable Events
• IRB – Post Approval Submissions

Classes are open to all UC Davis faculty, staff and students. Zoom advance registration is required. Zoom registration information will be sent after LMS registration is completed.

IRB – New Projects Submissions

When: THURSDAY, SEPTEMBER 10, 2020, 9 – 10:30AM

Where: Zoom

Register: uc.sumtotal.host…

Designed for researchers new to human subjects research at UC Davis who submit new projects to the IRB, attendees will learn when and how to apply for IRB review and how to navigate our electronic submission system, IRBNet. During this interactive course we will focus on the process of submitting a New Project application and corresponding with the IRB. Attendees should create an IRBNet account prior to attending class.

ICF Fundamentals – Pt. 1: Developing Informed Consent Documents

When: THURSDAY, SEPTEMBER 17, 2020, 9 – 10AM

Where: Zoom

Register: uc.sumtotal.host…

In Part 1 of this interactive course, we will focus on developing the consent document. Representatives from IRB Administration will discuss the legal requirements of consent documents, highlight common problems, and provide practical tips to improve your application to the IRB. Attendees will review a consent document from the IRB’s perspective to determine if it meets the criteria for approval. We will also discuss options for developing consent documents when language barriers exist.

IRB Reporting Requirements – Minor Deviations and Reportable Events

When: TUESDAY, OCTOBER 13, 2020, 9 – 10AM

Where: Zoom

Register: uc.sumtotal.host…

Designed for those who submit to the IRB, attendees will learn how to identify a reportable event, what to report to the IRB and a process for developing an effective Corrective and Preventative Action Plan (CAPA).

IRB – Post Approval Submissions

When: THURSDAY, OCTOBER 22, 2020, 9 – 10AM

Where: Zoom

Register: uc.sumtotal.host…

Designed for researchers new to human subjects research at UC Davis who submit post approval submissions to the IRB. Attendees will learn when and how to maintain IRB approval, what the IRB is looking for during the review process, and how to navigate our electronic submission system, IRBNet. During this interactive course we will focus on the process of post approval submissions, corresponding with the IRB, and securing approval documents to maintain compliance. Attendees should create an IRBNet account prior to attending class.

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September 2, 2020

The IRB Non-Committee Reviewer Analyst position has posted for recruitment.

Brief Description:

Under the direction of the Non-Committee Review Supervisor, use Institutional Review Board (IRB) knowledge and experience to apply complex federal, state and university regulations, policies and guidelines for human subject protection to ensure the protection of human subjects in research. Perform protocol screening, expedited reviews, reviews of reports of new information (RNIs), Investigator Brochures, and forward of project submissions for consideration by full IRB committees; serve as an IRB member who, by designation of an IRB chair, conducts non-committee reviews. Provide analytical support to the IRB Committee by conducting review and analysis of every submission the Committee will review and applying regulations, state law, official guidance and UC Davis standard operating procedures (SOPs) to determine gaps between the proposed research and applicable law and SOPs. Make recommendations based on experience and knowledge and work with investigators, Committee Members and others to resolve issues identified during analysis in a time sensitive manner. Efficiently coordinate and manage IRB Committee meetings. Demonstrate professionalism at all times and maintain collaborative rapport with the research community with a commitment to deliver exceptional customer service in all interactions.

This position frequently interacts with IRB Committee members, investigators, other department personnel and external constituents and must rely on independent judgment, expertise, knowledge of standards and best practices to provide appropriate counseling to resolve a wide range of time-sensitive research compliance issues.

Individuals in this position must continuously pursue professional development to advance and maintain current knowledge of human subjects protection.

For Full Consideration Apply By: 9/15/2020

Requisition Number:  10346

Payroll Title:  RSCH CMPLNC ANL 4

Position Number: 02014999

Department: IRB ADMINISTRATION – 061811

Salary Range: $5,466.67 – $11,183.33/MO.

Quick Link To This Position: https://careerspub.universityofcalifornia.edu/psp/ucdavis/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&JobOpeningId=10346&PostingSeq=1&SiteId=7&languageCd=ENG&FOCUS=Applicant

Please feel free to contact OR-HR at [email protected] if you have any questions or need additional information.

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July 17, 2020

The IRB Support Analyst, IRB Committee and IRB Education Analyst position has posted for recruitment.

Brief Description:

Under supervision provide analytical support to the IRB Committee including coordinating IRB meetings, supporting educational activities, ensuring information on IRB Administration’s website is current, and maintaining IRB Administration’s document control.

For Full Consideration Apply By: 7/30/2020

Requisition Number:  6228

Payroll Title:  RSCH CMPLNC ANL 1

Position Number: 02023207

Department: IRB ADMINISTRATION – 061811

Salary Range: $19.54 – 39.27HR.

Quick Link To This Position: https://careerspub.universityofcalifornia.edu/psp/ucdavis/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&JobOpeningId=9085&PostingSeq=1&SiteId=7&languageCd=ENG&FOCUS=Applicant

Please feel free to contact OR-HR at [email protected] if you have any questions or need additional information.

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July 8, 2020

In this Edition:

• Upcoming IRB, Regulatory, Feasibility Office Hours
• Changes to IRB Review of Data Analysis Research

CTSC IRB, Regulatory, Feasibility Office Hours

Complimentary assistance with IRB, Regulatory and Feasibility questions. See attached flier for additional details.

• Date: July 10, 2020
• Time: 12 to 2 p.m.
• Place: https://ucdavis.zoom.us/j/596870816

Changes to IRB Review of Data Analysis Research

In the past, the UC Davis IRB had not been able to access all of the new exempt review categories which were created as part of the Revised Common Rule which went into effect in January 2019. Thanks to a collaboration between our office and UCOP, we will now be able to make exempt determinations for the following types of studies:

• Prospective and retrospective chart review studies involving the use of PHI  when not funded by a Federal agency
• Secondary use studies of privately held identifiable data (non-PHI) when not funded by a Federal agency

What does this mean for new studies we submit?

New studies which fall into one or both of the categories above will now receive an Exempt determination from the IRB. Furthermore, if there is no interaction with subjects as a part of the study, a consent process will not be required. As with all Exempt and Expedited studies reviewed under the Revised Common Rule, these studies will not have an expiration date and will not require continuing review. Furthermore, studies which receive an Exempt determination will not need to be closed with the IRB once they have been completed.

What about any existing studies we have open which fit into these new categories?

There is no need to submit anything to the IRB unless you wish to have your study re-reviewed as Exempt. The IRB will not automatically re-review any of these studies which are currently open. If/when a modification or renewal is submitted, we may transition them to an Exempt determination if they meet all the requirements of the Revised Common Rule. If you would like to request that your study be re-reviewed for an Exempt determination, please submit a modification. In most cases, this is not necessary and only increases the administrative burden to the Researchers and the IRB.

How is the IRB still ensuring that patients/subjects are protected with these new categories?

The risks of these types of studies are primarily the risks of a loss of privacy and confidentiality. As a part of the Revised Common Rule, the concept of Limited Review was introduced where the IRB conducts a normal Exempt level review but additionally performs a higher level review for privacy and confidentiality concerns. For studies which fit into the categories above, we will be conducting this Limited Review to ensure that our patients/subjects remain protected.

What if my research is funded by a Federal agency but otherwise fits into one or both of the above categories?

These new categories are part of a larger concept in the IRB world called “Flex Determinations”. Flex Determinations allow us to bend the Common Rule requirements so long as we apply commensurate protections (e.g. Limited Review) to ensure that subjects remain protected to the fullest extent possible. Because we must agree to follow the Common Rule exactly as a part of the Federal awards we receive, we cannot use Flex Determinations for studies which are funded by a Federal agency.

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May 29, 2020

Dear Colleagues:

Aligning with the recent updates in guidance from Yolo and Sacramento counties, we will move our research ramp-up plans to Phase 2 effective June 1, 2020. Details of the Phase 2 were shared in our earlier guidance. Highlights of the activities are summarized as follows.

PHASE 2: Time-sensitive research activities (~33% of research personnel on-site at any time)

• Seasonal data collection such as field and agricultural work, time-sensitive human subject research studies, experiments close to completion, or deadline driven, whose pause or deferral would lead to long delays or loss of research results.
• Generation-driven animal and plant experimentation must be carried out or the value of the animal colony or plant varieties for research will be lost.
• Lab and studio access for students and postdocs close to completing their degree/term of appointment. Research that is critical to meet thesis requirements for a final defense in the upcoming term, or requirements before a graduating student can start a new position that has already been accepted.
• Necessary core facilities should be staffed and operational to support only the ongoing research activities during this phase. Research activities dependent on core facilities may thus be having a gradual ramp-up during this phase and will be vetted through a process defined by the core facilities directors and the concerned Dean/VCR.
• Lab should be able to purchase necessary supplies, including proper PPE and those necessary for proper decontamination of surfaces.

All the ongoing efforts approved for Phase 1 and 1x can choose to move to Phase 2 gradually and cautiously. As planned, there is very little ramping range from Phase 1x to Phase 2. No further approval is required unless mandated by the unit chairs/deans/directors. Restarting of new efforts will have to be coordinated with the chairs/deans/directors corresponding to the units, following the process that was defined for Phase 1x.

Please read through the guidance again and continue to utilize our best practices to mitigate the potential for COVID-19 spread in our campus community.

Stay healthy,

Prasant

Prasant Mohapatra
Vice Chancellor for Research
Distinguished Professor of Computer Science
University of California, Davis
Tel. 530-754-7764
https://research.ucdavis.edu
http://faculty.engineering.ucdavis.edu/mohapatra/

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May 26, 2020

In this edition

• Website Updates for Minor Deviations
• COVID-19 Guidance Updates

Website Updates

Minor Deviations

We’ve added to our list of example minor deviations! This list now includes a lapse in CITI training. To qualify as a minor deviation the following have to be true:

• The lapse is no more than 30 days
• No procedures were conducted by the staff with lapsed training that could have a significant impact on a subject’s rights, safety, or welfare
  • Examples of procedures which could have a significant impact on a subject’s rights, safety, or welfare include, but are not limited to, informed consent and study drug administration.
• No procedures were conducted by the staff with lapsed training that could have a significant impact on the integrity of the data
  • Examples of procedures which could have a significant impact on the integrity of the data include, but are not limited to, eCRF locking and collection of vital signs directly from a subject.

COVID-19 Guidance

Obtaining and Documenting Consent and HIPAA Authorization for Research

We’ve updated this section to respond to the ramp-up of research that is slowly occurring across both campuses. Specifically we’ve included notation that the waivers/alterations to the consent and HIPAA authorization processes (including use of DocuSign for FDA-regulated studies) are only in effect while in-person activities are suspended on a project.

We ask that all of our researchers keep in mind that during the coming months research may ramp-up and ramp-down again quickly as the campuses respond to various factors including seasonal changes, potential surges, and updated safety guidelines. As such, any research which is ramped-up may need to be quickly ramped-down again.

Use of DocuSign to Obtain E-Signatures

In response to the gradual ramp-up of research occurring across both campuses, we have updated our DocuSign guidance. Specifically, as in-person visits resume we are instructing researchers who have used DocuSign to document consent on FDA-regulated studies to re-consent subjects via traditional means who come in for in-person visits. This re-consent is not necessary for subjects who have either fully completed all study activities or who have no remaining in-person visits.

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May 12, 2020

Ramp-Up of Human Subjects Research During Phase 1X

As announced by the Office of Research (OR) and School Of Medicine (SOM), the campuses are entering Phase 1X of the research ramp-up plan (OR Guidelines, SOM Guidelines). During this period there will be a gradual ramp-up of research activities from those categorized as Phase 2 (time sensitive research activities), while still maintaining adherence to public health guidance and hazard mitigation strategies. As described in the Ramp-Up Plan, “time sensitive research activities” are those relating to seasonal data collection or human subjects research studies whose pause or deferral would lead to long delays (beyond the ramp-down period) or loss of research results. When determining whether or not a study is “time sensitive” consideration should not be given to grant or publication deadlines unless the study is directly tied to providing treatment or mitigation strategies for the current COVID pandemic. When thinking about which research studies/activities to resume during this time, please keep in mind that the ramp-up/ramp-down process could go in either direction so it is important to only re-initiate studies/activities which can be quickly ramped-down if needed. Page 8 of the Ramp-Up plan details the process for PIs to use if they would like to resume research studies/activities which would normally only be allowed in Phase 2 during Phase 1X.

The SOM Office of Research (SOMOR) has provided additional instructions for PIs seeking to resume research studies/activities under Phase 1X including a formal agreement between SOM and the PI to be signed by the PI and provided to their department chair. SOMOR has provided the following instruction for Department Chair’s when processing requests from PIs:

Please, follow the steps on this instruction; read the guidelines and ask your PIs to read them and to fill out the application form (bottom of the guidelines). Once you approve your PIs operation, please, keep their signed PI Agreement for your records and forward the approved application form to VCR Mohapatra’s office (Perry King; [email protected]).

You will only need to perform this Phase 1X selection process until Phase 2 of the Ramp up will be in effect. Thank you.

Ramp-Up/Ramp-Down of Research Studies/Activities

During the next many months the campuses will be assessing the ability for researchers to ramp-up their research studies/activities across campus. Please visit the Office of Research website on Research Continuity & Planning for COVID-19 during this time for updates on what phase of the ramp-up plan the campuses are in as well as any changes to the Ramp-Up Plan which may be published. Please keep in mind that as ramp-up occurs it is also possible that ramp-down may need to occur as well. Researchers should be mindful of this and have in place the ability to ramp-down research quickly if needed.

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April 6, 2020

Courtesy Announcement – Emergency COVID-19 Research Seed Funding Opportunity Offered by the UC Research Grants Program Office

See details here.

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March 30, 2020

In this edition:

• DHHS Secretarial Declaration
• CTSC Lunch & Learn Series – Research Video Visits
• New UCDH Guidance: Use of Video for Clinical Research

DHHS Secretarial Declaration

The Secretary of DHHS has limited the ability of persons receiving drugs, biologics, and devices to cure, mitigate, treat, prevent, or diagnose COVID-19 to sue manufacturers, distributors, program planners, providers, and sponsors (among others) for damages related to the provision or use of such drugs, biologics, or devices. As such, the IRB will be working to ensure that the following language is included in the ICF for any study which meets the above criteria:

Due to the coronavirus public health crisis, the federal government has issued an order that may limit your right to sue if you are injured or harmed while participating in this COVID-19 clinical study. If the order applies, it limits your right to sue the researchers, healthcare providers, any study sponsor or manufacturer or distributor involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.

If you are developing a study which will meet the above criteria, please ensure that this language is inserted in the ICF immediately following the template injury language. Ensuring that this information is included with the submitted ICF will limit the amount of revisions which are needed before approval can be granted.

CTSC Lunch & Learn Series – Research Video Visits

UCDH Research Video Visits Policy

During this discussion we will review UCDH Research Video Visits Guidance. This guidance complements the overarching Use of Video for Direct Patient Care guidance and the Research Continuity and Planning for COVID-19 guidance from the UC Davis Office of Research.

DATE: Wednesday, April 1, 2020

TIME: 12:30 – 1:00 p.m.

SPEAKER: Jana Katz-Bell (SOM, SON), Kate Marusina (CTO)

Advance Registration Required: https://ucdavis.zoom.us/meeting/register/uZIkcOutrjsondBBETnmsGfaMASOiR6B9A

UCD IRB Guidance & Telehealth Principles

During this discussion we will review IRB guidance for Research Video Visits and different methods for incorporating telehealth practices into research and clinical trials. Discussion will include communication best practices, logistical set-up, and institution requirements.

DATE: Thursday, April 2, 2020

TIME: 12:30 – 1:30 p.m.

SPEAKER: Benjamin Mooso (IRB), Lauren Bullard (MIND)

Advance Registration Required: https://ucdavis.zoom.us/meeting/register/uZQpfu-spzgpYYDLPKYvTcGCxXn-LCzlZg

Epic MyChart Video Visits Overview

During this discussion we will review workflows for using Epic MyChart for research video visits. Demo to be presented.

DATE: Friday, April 3, 2020

TIME: 12:30 – 1:00 p.m.

SPEAKER: Matt Wolfe (EMR Research)

Advance Registration Required: https://ucdavis.zoom.us/meeting/register/u5Quc-mqpjssh2DoSDKCxKQodzW0K2hpUA

New UCDH Guidance: Use of Video for Clinical Research

Two new guidance documents are now available on the COVID-19 page of the Insider (under Clinical Resources).

• Video for Resident/Fellow Education
• Video for Clinical Research.

The new guidance can be found here: https://intranet.ucdmc.ucdavis.edu/internal-news/ucdhs/2019-novel-coronavirus-information-and-resources-for-employees/2020/02

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March 26, 2020

Use of DocuSign to Obtain E-Signatures

DocuSign is now available for use to capture e-signatures on informed consent and HIPAA Authorization forms.

• The UC Davis licensed version of DocuSign is compliant with all requirements of FERPA, HIPAA, HRP-090 and HRP-091.
• The UC Davis licensed version of DocuSign has not been evaluated for 21 CFR Part 11 compliance. However, limited use of DocuSign for FDA-regulated studies is being allowed by UC Davis Health only if the research offers potential direct benefit to subjects, and with additional documentation requirements as directed below.

How to access to DocuSign

UC Davis Campus Researchers – Instructions and training resources are available  here: http://kb.ucdavis.edu/?id=1432

 UC Davis Health Researchers – Submit an access request to the Service Now portal for each research team member who will utilize (i.e. send, sign, create form, etc.) DocuSign.

• Access the Service Now portal here: https://ucdh.service-now.com/itss
  • See: How to Request DocuSign Access
• Training resources will be provided to users in response to their service request.
• If you are seeking to use DocuSign for consent/Authorization of a COVID-19 related study, please indicate this in the access request.

Guidance for all studies using DocuSign

Security – For security reasons, research subjects or their legally authorized representative (LAR) should not use publicly available devices for e-signing informed consents and HIPAA Authorization forms. The subject or LAR should utilize a privately-owned device to which they have regular access and use.

IRB Approval Not Required – At this time it is not necessary to submit a prospective modification to the IRB requesting to use DocuSign for obtaining signed consent and HIPAA authorization. If the study’s approved Initial Review Application and/or research protocol specifically state that consent will be obtained in-person, create a note to file in the study record and update the study documents at the next necessary modification.

Additional Guidance for studies subject to Part 11 (research involving drugs, biological, and devices regulated by FDA) using DocuSign

Limited Use – The use of the current UC Davis licensed version of DocuSign for FDA-regulated studies is only approved for use until further notice and may be subject to further FDA Guidance.

Documentation Requirements – In addition to existing documentation requirements, use of DocuSign for a FDA-regulated research study requires the following information be expressly noted in the research file:

• Need – Document the need to obtain remote consent during the COVID-19 public health emergency.
• Verification of Identity – When using DocuSign, research personnel must ensure there is a standard process to verify the identity of the individual who signs the documents. Document both verification of identity and the process. See more information here.
• Informed Consent Conversation – Document that the informed consent conversation occurred, the method by which it occurred (e.g. telephone call, telehealth encounter), and the subject’s understanding of the information presented to them.
• Verification of Signature – A participant/LAR will often e-sign the ICF and/or HIPAA Authorization during the informed consent conversation. When this occurs, it should be noted in the file.  In the event the documents are signed by the participant or LAR after the informed consent conversation ended, the researcher must conduct a follow-up conversation with the participant or LAR. After providing an opportunity to ask questions, verify and document the following:
  • Confirm that the individual who engaged in the informed consent conversation signed the DocuSign forms; and
    • • Confirm that the consent and Authorization remain in effect.

Additional Considerations for FDA-regulated studies

• Please discuss the use of DocuSign with your sponsor(s) of FDA-regulated studies prior to implementing use of DocuSign. The UC Davis licensed version of DocuSign has not been evaluated for 21 CFR Part 11 compliance. However, limited use of DocuSign for FDA-regulated studies is being allowed by UC Davis Health until further notice.
• Prior to beginning the electronic consent process, researchers and their teams should review the joint FDA/OHRP guidance on using electronic consent in FDA-regulated research:  Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers.

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March 19, 2020

Best practices for the conduct of human subjects research during the COVID-19 pandemic are evolving rapidly. Researchers can find current guidance and resources from UC Davis, FDA, NIH and other stakeholders here.

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March 18, 2020

COVID-19 Update

Due to the rapidly evolving concerns and risks related to the COVID-19 outbreak, the UC Davis Institutional Review Board (IRB) Administration is recommending that study investigators take specific actions to limit transmission of the virus by delaying or otherwise modifying non-essential interactions. In particular, the IRB Administration recommends that research involving immunocompromised or elderly at-risk participants, or research that involves group meetings or appointments, consider delaying or using alternative interactions via electronic means if possible. Appropriate changes such as these — related to the COVID-19 outbreak — are considered minor deviations and are not required to be reported to the IRB. These modifications may be implemented prior to IRB approval when it is necessary to eliminate apparent immediate hazards to the subject (§46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4)).

Resources for Researchers

• UC Davis: Office of Research guidance for reducing on-campus research activities
• UC Davis: TeleWork Tech Tools
• UCDMC: Guidance to Researchers Regarding Determination of whether a human research visit should take place onsite at UC Davis during the COVID-19 outbreak
• UCDMC: Script for Research Related Visits During the Coronavirus Outbreak
• NIH: Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19
• FDA: Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
• FDA: Guidance: Part 11, Electronic Records, Electronic Signatures – Scope and Application

Obtaining and Documenting Consent and HIPAA Authorization for Research

• Enrollment into studies that require in-person contact should be limited to research that has the potential of direct benefit that is critical to participant safety and in their best interest.
• If research does not have the potential of direct benefit that is critical to participant safety, all interactions with participants should be remote. In-person interactions should temporarily halt until social distancing is no longer required.
• A complete informed consent process must be conducted for participant enrollment, unless previously waived by the IRB. Acceptable remote methods of consent include mailing, emailing, and faxing of consent documents and telephone or video contact with potential research subjects.
• The IRB has determined that is impracticable to obtain in-person signatures on consent forms when study visits are remote. If research has the potential of direct benefit that is critical to participant safety and enrollment requires a signed consent form, the IRB waives the requirement for signed consent. When this occurs, researchers should document that oral consent has been obtained and should make every attempt to obtain a signed consent document upon the cessation of social distancing requirements. This waiver is only in effect for studies which provide direct benefit to subjects.
• When accessing, using or disclosing PHI a signed HIPAA authorization form is required. Acceptable remote methods of obtaining authorization include mailing, emailing, and faxing of HIPAA authorization forms and telephone or video contact with potential research subjects.
• The IRB has determined that it is impracticable to obtain in-person signatures on HIPAA authorization forms when study visits are remote. If research has the potential of direct benefit that is critical to participant safety and enrollment requires a signed HIPAA authorization form, the IRB waives the requirement for HIPAA authorization for research. Unlike research consent, oral authorization for HIPAA is not allowed. Researchers should document that the requirement of HIPAA authorization has been waived by the IRB due to the COID-19 pandemic and should make every attempt to obtain a signed authorization upon the cessation of social distancing requirements. This waiver is only in effect for studies which provide direct benefit to subjects.
• You must use HIPAA compliant practices when emailing or faxing documents which may contain PHI when paired with a signature (e.g. diagnoses).

Study Visits

• All study visits that do not require in-person contact should be conducted remotely.
• Follow UCDMC: Guidance to Researchers Regarding Determination of whether a human research visit should take place onsite at UC Davis during the COVID-19 outbreak.
• Use UCDMC: Script for Research Related Visits During the Coronavirus Outbreak to determine if the participant is eligible for an in-person visit. This script may be used without prior IRB approval, in accordance with §46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4).
• For sponsored research, obtain sponsor approval prior to implementing changes unless the change is necessary to eliminate apparent immediate hazards to subjects.
• For FDA-regulated research, changes to the protocol or investigational plan to minimize or eliminate immediate hazards or to protect the life and well-being of research participants (e.g., to limit exposure to COVID-19) may be implemented without IRB approval or before filing an amendment to the IND or IDE, but are required to be reported afterwards. These changes should be recorded as minor deviations and submitted to the IRB at continuing review.
• Follow current UCOP, campus, facility or clinic COVID19 safety measures all times.

There are many telework tools available to UC Davis researchers. Each research team should ensure they are appropriately safeguarding research participants’ privacy and the confidentiality of the research data. Options to consider for remote visits:

• For research participants who also have MyChart, schedule a video visit.
• Hold remote interviews or group meetings via Zoom or WebEx.
• Transition questionnaires and surveys to an online format such as Qualtrics or REDCap.

Please do not delay or otherwise modify interventions that are in the subject’s best interest. Patients with any acute respiratory complaints should not be triaged by their research physicians but should seek initial care through their PCP. For more information or if you have questions please contact the IRB at [email protected] or (916) 703-9158.

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March 16, 2020

Due to the rapidly evolving concerns and risks related to the COVID-19 outbreak, the UC Davis Institutional Review Board (IRB) Administration is recommending that study investigators take specific actions to limit transmission of the virus by delaying or otherwise modifying non-essential interactions. In particular, the IRB Administration recommends that research involving immunocompromised or elderly at-risk participants, or research that involves group meetings or appointments, consider delaying or using alternative interactions via electronic means if possible. Appropriate changes such as these — related to the COVID-19 outbreak — are considered minor deviations and are not required to be reported to the IRB. These modifications may be implemented prior to IRB approval when it is necessary to eliminate apparent immediate hazards to the subject (§46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4)).

When scheduling study visits:

• Review the attached UCDMC guidance on assessing whether a human research visit should take place onsite at UC Davis during the COVID-19 outbreak.
• Use the screening script to determine if the participant is eligible for an in-person visit. This script may be used without prior IRB approval, in accordance with §46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4).
• For sponsored research, obtain sponsor approval prior to implementing changes unless the change is necessary to eliminate apparent immediate hazards to subjects.
• Follow current UCOP, campus, facility or clinic COVID19 safety measures all times.

There are many telework tools available to UC Davis researchers. Each research team should ensure they are appropriately safeguarding research participants’ privacy and the confidentiality of the research data. Options to consider for remote visits:

• For research participants who also have MyChart, schedule a video visit.
• Hold remote interviews or group meetings via Zoom or WebEx.
• Transition questionnaires and surveys to an online format such as Qualtrics or REDCap.

Please do not delay or otherwise modify interventions that are in the subject’s best interest. Patients with any acute respiratory complaints should not be triaged by their research physicians but should seek initial care through their PCP. For more information or if you have questions please contact the IRB at [email protected] or (916) 703-9158.

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March 12, 2020

Research continuity and planning for COVID-19

Due to the rapidly evolving concerns and risks related to the COVID-19 outbreak, the UC Davis Institutional Review Board (IRB) Administration is recommending that study investigators take specific actions to limit transmission of the virus by delaying or otherwise modifying non-essential interactions. In particular, the IRB Administration recommends that research involving immunocompromised or elderly at-risk participants, or research that involves group meetings or appointments, consider delaying or using alternative interactions via electronic means if possible. Appropriate changes such as these — related to the COVID-19 outbreak — are considered minor deviations and are not required to be reported to the IRB. Please do not delay or otherwise modify interventions that are in the subject’s best interest. For more information or if you have questions please contact the IRB at [email protected] or (916) 703-9158.

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In this Section

• • • *New* Self-guided Online Training Options
    • *New* Response Memo Template
    • Active Recruitment: IRB Reliance Analyst
    • IRB Review Times

*New* Self-guided Online Training Options

Two of our most requested training classes are now available in an interactive, online format:

• • • Outside Financial Interest Reporting in Human Research
    • IRB Overview: Submission Types, Forms, Review Process

We are working to make these courses available in LMS. We will send out additional details when they are available

*New* Response Memo Template

In collaboration with the Clinical Trials Office, we offer this new resource to investigators submitting a Response/Follow-up application to the IRB:

• • • Response Memo Template

Active Recruitment: IRB Reliance Analyst

Brief Description: Under general supervision of the Director of IRB Administration, work with a Non-Committee Reviewer to coordinate activities related to IRB reliances where external researchers or institutions rely on UC Davis IRB and where UC Davis relies on an external IRB for review of human subject research.

For Full Consideration Apply By: 11/15/2019

Requisition Number:  2168

Payroll Title:  RSCH CMPLNC ANL 3

Position Number: 02022597

Department: IRB ADMINISTRATION – 061811

Salary Range: $60,800.00 – $122,100.00 / YR

Quick Link To This Position: https://careerspub.universityofcalifornia.edu/psp/ucdavis/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&JobOpeningId=2168&PostingSeq=1&SiteId=7&languageCd=ENG&FOCUS=Applicant

Please feel free to contact OR-HR at [email protected] if you have any questions or need additional information.

IRB Review Times

Due to increased volume of applications and current staff vacancies within IRB Administration, you may experience longer than typical processing times for IRB applications. We are currently reviewing applications within 3-4 weeks. We appreciate your patience.

Posted May 18, 2018

New HIPAA Authorization Form (Version 2017)

The updated HIPAA authorization form (Version 2017) will be required for use with studies obtaining UC Davis IRB, UCOP Reliance Registry, or central IRB approval (IRB approval) on or after June 1, 2018. Researchers may continue to use HIPAA authorization form Version “Updated 5/14” for studies that received IRB approval prior to June 1, 2018. Click here to view the updated form. Click here for information about which version of the HIPAA Authorization to use.

Policy Update: P&P 2306 – Medical Record Content

Policy Update: Documentation of Research Patient Status in the EMR

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Posted January 22, 2018

Hold that thought – The New Rule has been delayed!

On January 17, 2018 the U.S. Office for Human Research Protections announced that the effective date of the 2018 Common Rule will be delayed until July 19, 2018. More information will be provided as it becomes available. For background information on the New Rule and how these changes will impact UC Davis researchers, click here.

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Posted January 2, 2018

New Year, New Rule

Changes to human subject research regulations take effect January 2018. Click here to read about how these changes impact UC Davis researchers. Click here to read more about the New Common Rule.

NIH Single IRB Requirement

Effective January 2018, many NIH-funded multi-site human subjects research projects must comply with a new single IRB review requirement. Click here for information about this policy at UC Davis. Click here for information from NIH. Contact the UC Davis IRB Reliance group if your research requires a plan for single IRB review.

AAHRPP is Coming

UC Davis is currently undergoing reaccreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The AAHRPP site visit is scheduled for February 15 and 16, 2018. During the site visit AAHRPP representatives will review the university’s plan and policies for protecting humans involved in research by reviewing records and interviewing employees at UC Davis. Those employees selected for interviews have been notified by the IRB Director.

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Posted November 9, 2017

CTSC Clinical Trials Office – StudyPages

The CTSC Clinical Trials Office is excited to announce StudyPages, a new state of the art participant recruitment management platform. The platform assists with study recruitment by generating attractive, community-friendly web pages easily shareable via social media platforms. The pages could also be used as flyers for posting, mailing or emailing. Paid social media campaigns could be added at the discretion of the study teams.

StudyPages also provides capabilities for tracking communication with participants (or prospective participants) by secure email, SMS, or phone messaging. The participant management platform is a powerful tool that allows study teams to keep a log of study specific communications with participants and notes. The platform is available with or without a public-facing StudyPages webpage.

The UC Davis IRB published a Standard Operating Procedure HRP-92 aiming to aid the investigators and study teams in creating StudyPages that adhere to the Federal and local regulations. By following this SOP, the study teams can publish StudyPages without an additional IRB approval.

The StudyPages partnership also entails automatic addition of the IRB-approved studies already published on clinicaltrials.gov. Information from clinicaltrials.gov is uploaded into StudyPages weekly. Some of the most difficult scientific terms in the study title and the introductory paragraph is modified to the 8th grade language to make the text more user-friendly for the community. A link connects automatically generated StudyPage to the original clinicaltrials.gov entry.

When the study closes to recruitment and the study status changes in the IRB database, the StudyPages posting is removed from the gallery. The CTO also removes automatically-generated entries by the PI’s request.

To use this platform visit https://studypages.com/ucdavis. Kerberos log in is required.

With any questions, please contact Kate Marusina, Ph.D., Director, Clinical Trials Office

Kate Marusina, Ph.D., MBA
Director, CTSC Clinical Trials Office
Associate Director, CTSC Regulatory Knowledge and Support
2921 Stockton Blvd, Suite 1400
Sacramento, CA 95817
[email protected]
916-703-9177 (office)
530-979-1522 (mobile)
www.ucdmc.ucdavis.edu/clinicaltrials

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Posted November 3, 2017

In this edition:

• • 1. Most NIH studies involving human subjects are now automatically covered by a Certificate of Confidentiality. If you are conducting NIH funded human subject research, this new policy will affect the conduct of your research.
    2. NIH will soon require only one IRB to review NIH funded non-exempt multi-site human subject research conducted in the United States.
    3. IRB Administration is revising its process for acknowledging reportable events.
    4. UC Davis is undergoing reaccreditation with the Association for the Accreditation of Human Research Protection Programs.

1. NIH Funding and Certificates of Confidentiality

The NIH updated its policy for issuing Certificates of Confidentiality (CoC’s) for NIH-funded research. The updated policy states that all research that was commenced or ongoing on or after December 13, 2016 that is within the scope of the policy is deemed to be issued a CoC through this Policy and is therefore required to protect the privacy of individuals who are subjects of such research. The policy applies to research where the following may occur:

• • • An individual is identified in research data or for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.
    • Sensitive information includes biospecimens, human genomic data from biospecimens, and any other data if the information is about an individual.

Consequently, almost all NIH funded human subject research is now covered by a CoC even though no application for the certificate was submitted.

When research is covered by a CoC, investigators and research staff must not disclose in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of any individual or provide anything that contains identifiable, sensitive information about any individual created or compiled for purposes of the research to any person, court, agency, or office for any reason except as listed below without first obtaining consent from the individual about whom the information pertains.

Disclosure is permitted only when:

• • • Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or laws requiring the reporting of communicable diseases to health departments),
    • Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
    • Made with the consent of the individual to whom the information, document, or biospecimen pertains; or
    • Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

Investigators conducting research applicable to this Policy are required to establish and maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with the policy. Investigators must ensure that recipient investigators/institutions who receives a copy of identifiable, sensitive information protected by a Certificate understand they are also subject to the requirements of the policy and are also responsible for ensuring compliance with the policy. For studies in which informed consent is sought, NIH expects investigators to inform research participants of the protections and the limits to protections provided by a Certificate issued by this Policy.

In sum:

• • • Almost all human subject research funded or supported by the NIH is now covered by a CoC.
    • NIH awardees no longer have to apply for a Certificate of Confidentiality.
    • Consent documents must be revised to include new language about the CoC.
    • Investigators and research staff must take extra precautions to protect the data.
    • IRB Administration will be sending notices to PIs who need to revise consent documents to comply with this policy.

Additional information such as FAQs will be available at the NIH Certificates of Confidentiality.

2. Single IRB Review

The NIH will soon be requiring the proposed research be reviewed by only one IRB. This single IRB (sIRB) policy will apply to non-exempt human subject research that is:

• • • Funded by NIH through a grant or contract; and
    • Includes more than one site in the United States who are conducting the same protocol.

The policy does not apply to:

• • • Research meeting the requirements for an exemption;
    • Foreign sites;
    • Research funded through career development (K), institutional training (T), and fellowship awards (F); and
    • Research conducted at sites for which federal, state, or tribal laws, regulations or policies require local IRB review.

Other exceptions to allow for local IRB review may be considered by NIH if there is compelling justification.

The effective date of this policy is January 25, 2018. The policy will apply to all competing grant applications for due dates on or after January 25, 2018; and for R&D contracts, the policy will apply to all solicitations issued on or after January 25, 2018.

If you are developing a proposal for NIH funding you must include the plan for sIRB review in the proposal and include the fees associated with sIRB in the budget.

If you are writing a proposal or collaborating on a proposal for NIH funding of research involving human subjects in which there is more than one domestic participating institution conducting the same protocol, you should contact the IRB at [email protected] as soon as possible.

Additional information about the NIH policy can be found HERE.

3. IRB Administration Notices Acknowledging Reportable Events

Currently the IRB acknowledges most reports of new information (FORM HRP-214) by signing on a signature block at the bottom of the first page of the report. In the next few weeks, the IRB will begin sending written notices acknowledging these reports. These notices will be similar to the notices IRB Administration uploads into IRBNet to provide the IRB’s determination in response to a submission. Investigators will no longer receive a signed copy of the HRP-214 and will only receive the notification. The notice will include a list of the documents submitted and a description of the event being acknowledged. The notice will also allow the IRB to send additional comments in response to the report.

4. AAHRPP ACCREDITATION

UC Davis is currently undergoing reaccreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP). AHRPP accredits high-quality human research protection programs in order to promote excellent, ethically sound research. Through partnerships with research organizations, researchers, sponsors, and the public, AAHRPP encourages effective, efficient, and innovative systems of protection for human research participants. As the “gold seal,” AAHRPP accreditation offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an institution’s human research protection plan is focused first and foremost on excellence.

During this process AAHRPP representatives will review the university’s plan and policies for protecting humans involved in research. Representatives will visit the campus to:

• • • Look at records pertaining to human subject protections; and
    • Interview employees and IRB Committee members involved in any aspect of research involving human subjects to determine their knowledge of the ethics, law, and UC Davis policies related to protections of human subjects in research.

You may be asked to participate in an interview with AAHRPP representatives. We will be providing more information on the accreditation process as soon as we learn when the AAHRPP representatives will be visiting our campus.

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Posted October 12, 2017

HRP-214 Update

Please note that the UC Davis IRB Administration revised FORM HRP-214 – Reportable New Information to require submission of reports that involve local unanticipated adverse device effects within five business days of knowledge of the event.

IRBNet- Sending project mail

When asking a question through IRBNet’s “Send Project Mail” function, please DO NOT select all board contacts to send a message. If you have a general question select the board contact, “Ask For, IRB Help.” By selecting “Ask For, IRB Help” your message will be sent to our education and training mailbox and an IRB staff member will respond. If you have a question for a specific person/people, select their name(s) from the board contacts list.

Upcoming IRB Training Events

IRB Protocol Writing Lab

Dates: November 8, 2017
Time: 3:00 – 4:30 pm
Location: Hoagland Hall, Room 260

During this hands-on protocol writing lab, you will work independently at a computer while an IRB Analyst guides you through two of the essential documents for IRB review of a new research project: HRP-503 Protocol Template and Initial Review Application. At the end of the session you should have a clear idea of the information needed to complete the application and how to submit an application for IRB Review. This class is designed to complement the IRB New Submitter Class. Registration through the UC Learning Management Center is required.

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Posted February 28, 2017

IRB Office Hours Update

In order to provide UC Davis researchers the most effective and efficient assistance possible, IRB Administration is restructuring the IRB Office Hours Program. Through the month of March, IRB representatives will be available at the regularly scheduled times and locations only if researchers have scheduled an appointment. This change will allow IRB Administration to appropriately staff the Office Hours session. If no appointment is scheduled two hours before the start time of the Office Hours session, the session will be cancelled. Click here to schedule an appointment.

Starting April 3, the UC Davis IRB will no longer hold Office Hours but will provide consultation services upon request. Researchers can email a consultation request to IRB Administration to schedule an appointment with an experienced IRB Analyst. The consultation will be scheduled for a mutually agreed upon time and location. Click here to request a consultation.

Eligibility to act as Principal Investigator

The IRB’s policy regarding eligibility to act as Principal Investigator when research does not receive external funding has been updated. For more information please review the Principal Investigator Qualifications posted on our website.

NIH Training Requirement Reminder

The NIH now requires Good Clinical Practice training for Social and Behavioral Research that meets the definition of a clinical trial. A new course has been developed specifically to address clinical trials using behavioral interventions and social science research. The course, titled “NIH Good Clinical Practice” is available now through the UC Davis Learning Management System. Once you are in the system, search for NIH Good Clinical Practice to access the modules.

Upcoming IRB Training Events

CRC 2.0: IRB Submissions: Commonly Seen Mistakes and Best Practices

Sacramento
Date: April 6, 2017
Time: 2:00 – 5:00 pm
Location: Medical Education Building, Room 3202

Hosted by the Clinical Trials Office, this course is designed for those knowledgeable in IRB review and will outline the most common errors in IRB submissions. Attendees will review projects from the IRB’s perspective and will learn how to screen their own projects for problems prior to submitting to the IRB. Registration through the UC Learning Management Center is required.

IRB New Submitter Training

Davis
Date: May 9, 2017
Time: 1:00 – 3:00 pm
Location: Hoagland Hall, Room 260

Designed for researchers new to human subjects research at UC Davis, this course includes an introduction to our electronic submission system, IRBNet, a description of the types of projects which require IRB review, an overview of the IRB review process, and an outline of IRB submission types and required documents. Attendees will learn guidelines for successful submissions to the IRB. Registration through the UC Learning Management Center is required.

New Class: IRB Protocol Writing Lab

Davis
Dates: May 9, 2017
Time: 3:00 – 4:30 pm
Location: Hoagland Hall, Room 260

During this hands-on protocol writing lab, you will work independently at a computer while an IRB Analyst guides you through two of the essential documents for IRB review of a new research project: HRP-503 Protocol Template and Initial Review Application. At the end of the session you should have a clear idea of the information needed to complete the application and how to submit an application for IRB Review. This class is designed to complement the IRB New Submitter Class. Registration through the UC Learning Management Center is required.

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Posted January 27, 2017

UC Davis IRB Implements 10-year Approval Periods

The final revised Common Rule was published January 19, 2017. One new provision eliminates the requirement for continuing review on studies involving only minimal risk. The rule does not become effective until January, 2018, however, UC Davis IRB Administration is taking action to reduce administrative burden for researchers today, as allowed under the current regulations.

Effective immediately IRB Administration will be is issuing 10-year approval periods for studies that meet ALL of the following requirements:

• • • This research involves no more than minimal risk
    • This research does not receive any federal or state government funding or funding from a private funder who requires annual review per contract
    • This research Is not subject to FDA jurisdiction
    • This research does not include prisoners as participants
    • This research is not part of an IRB reliance
    • This research is not subject to SCRO oversight
    • This research is not subject to oversight by the Research Advisory Panel of California (RAP of C)
    • This research does not involve personnel supported by federal training, center, or program grants
    • No personnel involved in the design, conduct, or reporting of this research have a related financial interest (RFI) in this study, or any existing RFIs have previously been reported and there are no changes to any previously reported RFI.

When 10 year approval is issued researchers will not need to submit an HRP 212 Continuing Review Progress Report until 45 days prior to the expiration date (10 years from approval) or at study closure, whichever comes first. Existing projects that meet the qualifications above will be granted a 10-year expiration date when we receive information from investigators that the study qualifies.

The HRP 212 FORM Continuing Review Report has been revised to allow investigators to report studies that qualify for a 10-year approval period. This form will be uploaded to IRB Administration’s website very soon. If the study meets the criteria for 10-year approval, investigators can complete the sections at the top of the form and submit it to the IRB. If the project qualifies, the IRB will issue a new, 10 approval period without conducting continuing review. The revised HRP 212 can be submitted at any time, but it must be submitted at least 45 days before the study was originally scheduled to expire.

Please note, investigators must continue to submit all changes to research prior to implementation and reportable new information items as currently required. In addition, investigators will receive an annual notice listing details of the research. Investigators must submit a modification if there are changes to any of the items listed in the notice.

We are currently working with our contacts at IRBNet to develop a process that will allow us to eliminate the need for entering an expiration date in the system. When the process has been established, we will no longer assign a 10-year expiration date and studies will remain approved until they are closed or approval is terminated.

When the revised Common Rule becomes effective, the IRB will further reduce the requirement for continuing review to include federally funded studies.

NIH Good Clinical Practice for Social and Behavioral Research Now Available

Effective January 1, 2017 all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

While CITI provides coursework in drug, device, or biologic research, a new course has been developed specifically to address clinical trials using behavioral interventions and social science research. The course, titled “NIH Good Clinical Practice” is available now through the UC Davis Learning Management System. Once you are in the system, search for NIH Good Clinical Practice to access the modules.

OHRP Releases Research Participant Website

A message from OHRP:

The Office for Human Research Protections (OHRP) is excited to announce the launch of its new public outreach website, About Research Participation! These resources are designed to help potential volunteers better understand research and ask for the information they need to decide whether to participate. This initiative broadens OHRP’s educational and outreach efforts to the general public.

The newly developed resources include a series of short videos about participating in research and a printable list of questions potential volunteers can ask researchers. Trial coordinators and research staff also could use these materials to facilitate and improve the informed consent process. No additional permission is required to use or disseminate these public resources.

We believe these materials will be a valuable resource for the research community as well as the general public. Please consider sharing this information broadly! We also welcome your feedback, and would be happy to receive comments on this initiative at [email protected].

A link to this website has been made available at the UC Davis IRB Research Participants website.

Updates to the HRP-503 Protocol Templates

There have been several significant changes to research oversight in the first month of 2017. To assist UC Davis researchers in assessing how these changes impact their projects, the HRP-503 Protocol Templates have been updated.

Two new sections have been added to the HRP-503 General Template:

• • 1. gov Registration: This section provides support when determining if research requires registration on clinicaltrials.gov,
    2. Criteria for 10-year Approval: This section assists researchers in securing 10-year approval by indicating to the IRB that all of the requirements have been met.

The Criteria for 10-year Approval section will also added to the specialized HRP 503 Record/Data/Specimen Review and HRP-503 Surveys/Interviews and/or Focus Groups Templates.

The revised templates will be available on our website next week.

Upcoming IRB Training

New Submitter Training

Designed for researchers new to human subject research at UC Davis, this course includes an introduction to our electronic submission system, IRBNet, a description of the types of projects which require IRB review, an overview of the IRB review process, and an outline of IRB submission types and required documents. Attendees will learn guidelines for successful submissions to the IRB. Registration is required through the UC Learning Center.

Date: February 8, 2017,
Time: 1:00 – 3:00 pm
Location: Hoagland Hall, Room 260
Davis, CA

 

CRC 2.0: IRB Submissions: Commonly Seen Mistakes and Best Practices

Hosted by the Clinical Trials Office, this course is designed for those knowledgeable in IRB review and will outline the most common errors in IRB submissions. Attendees will review projects from the IRB’s perspective and will learn how to screen their own projects for problems prior to submitting to the IRB. Registration is required through the UC Learning Center.

Date: February 16, 2017
Time: 2:00 – 5:00 pm
Location: Medical Education Building, Room 2205
Sacramento, CA

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Posted December 12, 2016

NIH GCP Training Requirement

Find attached the NIH policy statement on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.

Of note in this policy:
This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See https://grants.nih.gov/grants

This policy takes effect January 1, 2017.

How this affects you:
UC Davis researchers involved in the conduct, oversight, or management of biomedical or behavioral clinical trials receiving NIH support will be expected to complete GCP training. To fulfill this requirement UC Davis offers two courses through CITI. Choose the appropriate course based on the research you are conducting. Researchers are only required to take one GCP course. If conducting research with both drugs/biologics and devices, investigators should take the GCP course that applies to the majority of their research.

• • • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
    • GCP for Clinical Trials with Investigational Medical Devices

GCP training certification is valid for 3 years. When GCP training is due to expire, investigators may take a GCP refresher course to renew certification. There are two versions of the refresher course; researchers are only required to take one GCP refresher. Investigators should take the GCP refresher course that applies to the majority of their research.

For more information on enrolling in CITI courses visit the Required CITI Education page on our website http://research.ucdavis.edu/outreach/citi/

CCRP Exam Update

The Certified Clinical Research Professional (CCRP) exam date at UC Davis has changed from February 16^th, 2017 to February 27^th, 2017. Details can be found below. For more information about SOCRA and the CCRP exam click here.

Exam Date: February 27, 2017
Time: 5:00 – 9:00 p.m.
Exam Location: UC Davis CTSC Building, Sacramento
Application Deadline: January 16, 2017

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Posted November 18, 2016

IRBNet Automated Stamping

IRBNet now offers an automated document stamping process for IRB Administration use. The automated process allows for faster stamping of consent documents once they have been approved and reduces the possibility of errors in protocol numbers and approval dates found in the stamp. The new stamping process automatically converts documents from Word to PDF and applies a stamp in the lower right corner of each page.

The use of automated stamping depends on the proper formatting of documents. The automated process lacks the scale and placement tools that IRB staff have used to manually work around non-standard formatting.

To avoid problems with the new stamping process please follow these guidelines for consent documents:

• • 1. Set the bottom margin at 1.3”
    2. Save all pages in portrait orientation (not landscape)
    3. Submit consent documents as PDF files

HRP 502 Template Consent Form has been updated with a new bottom margin to allow adequate space for the stamp. Please use the revised template found on our website or the IRBNet Library when submitting new consent forms. When making edits to previously approved consent forms set the bottom margin to 1.3”. If you have any questions contact the IRB Education team at [email protected].

Template Risk Language

IRB Administration has developed standard language to assist researchers in providing complete and concise descriptions of risks commonly encountered in human subjects research. It is not a requirement that researchers use this language; it is provided as guidance. The new language can be found on our Forms page under Templates.

Upcoming Events

IRB New Submitter’s Class

Designed for researchers new to human subjects research at UC Davis, this course includes an introduction to our electronic submission system, IRBNet, a description of the types of projects which require IRB review, an overview of the IRB review process, and an outline of IRB submission types and required documents. Attendees will learn guidelines for successful submissions to the IRB. Registration is required through the UC Learning Center. To register for the class log into the UC Learning Center, search for “IRB,” select the course of interest and complete the registration process.

Date: November 29, 2016
Time: 1:00 – 3:00 pm
Location: Medical Education Building
Room 2205, Sacramento

Date: February 8, 2017
Time: 1:00 – 3:00 pm
Location: Hoagland Hall
Room 260, Davis

Certified Clinical Research Professionals (CCRP) Exam

SOCRA developed the Certified Clinical Research Professional Certification program to evaluate a CRP’s knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the International Conference on Harmonization Guideline for Good Clinical Practice (E6) (ICH/GCP), ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A), the United States Code of Federal Regulations (CFR) and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. This Examination does NOT test on state, provincial, Ministry of Health, local, or institutional policy. Click here for more information.

Exam Date: February 16, 2017

Time: 5:00 – 9:00 p.m.
Exam Location: UC Davis CTSC Building, Sacramento
Application Deadline: January 4, 2017

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Posted November 4, 2016

IRBNet Spotlight: New Document Management Tools

IRBNet is pleased to announce our powerful new document management tools, focused on streamlining and enhancing the Designer experience for your busy study teams. These enhancements dramatically reduce the effort required to assemble Submission Packages within the Designer.

Assemble and Manage Project Documents

The Designer has been enhanced to greatly reduce the number of clicks and navigational steps required to create, submit and manage Project Documents. Please note:

• • • Package Assembly. From the Designer, researchers with Write or Full access may now directly attach multiple documents at one time through upload or drag and drop techniques.
    • Smart Forms. Access and initiate Smart Forms directly from the Designer.
    • Package Description. The package description field provides the opportunity to capture and communicate additional detail about each package.
    • Document History. Easily add, remove, or move documents between Document Histories simply by dragging and dropping.
    • Package Navigator. This handy tool aids access to every submission package and document.
    • All Project Documents view. This subtle tool eases moving from viewing documents in a package to all documents associated with a project and make it easy to locate the most current version of any project document.

Create New Packages

In addition to these enhancements, the navigation experience to create new Packages has been streamlined. This function can now be accessed both from the new Package Navigator as well as Project Administration menu to the left of the screen.

Next Steps

Click here for a guide to the new tools. IRBNet plans to release these tools in the near future. If you would like additional information or assistance in learning the new tools, please contact the IRB Education group at [email protected] or visit our office hours. Details for office hours can be found below.

UCDMC Campus
Date: Every Tuesday
Time: 12 pm to 1 pm
Medical Education Building
Computer Lab 2106

UCD Campus
Date: Every Wednesday
Time: 12 pm to 1 pm
Mrak Hall
Room 61

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Posted September 29, 2016

Educational Opportunities for UC Davis Researchers

With each new academic year the IRB sees new investigators conducting human subjects research at UC Davis. IRB Administration provides support and education to UC Davis researchers with classroom training, weekly office hours, a comprehensive website, and a dedicated education phone line and email account. Below we’ve outlined ways you can learn more about human subjects protections and IRB review at UC Davis.

New Submitter’s Training

Dates: October 5, 2016, February 8, 2017, May 9, 2017
Time: 1:00-3:00 pm
Location: Hoagland Hall, Room 136, Davis, CA

Designed for those new to human subjects research at UC Davis, this course covers the types of projects which require IRB review, an overview of the IRB review process, an outline of IRB submission types and required documents, and an introduction to our electronic submission system, IRBNet. Attendees will learn guidelines for successful submissions to the IRB. Registration is required through the UC Learning Management System. Click here for more information.

CRC 2.0: IRB Submissions: Commonly seen mistakes and best practices

Dates: February 16, 2017, April 6, 2107
Time: 2:00-5:00 pm
Location: Medical Education Building, Room 2205, Sacramento, CA

Hosted by the Clinical Trials Office, this course is designed for those knowledgeable in IRB review and will outline the most common errors in IRB submissions. Attendees will review projects from the IRB’s perspective and will learn how to screen their own projects for problems prior to submitting to the IRB. Registration is required through the UC Learning Management System.

IRB Office Hours

Dates: Tuesdays
Time: 12:00-1:00 pm
Location: Medical Education Building, Room 2106, Sacramento, CA

Dates: Wednesdays
Time: 12:00-1:00 pm
Location: Mrak Hall, Room 61, Davis, CA

IRB Administration’s weekly office hours are an opportunity to seek one-on-one help with your project. An IRB analyst is available to answer your questions about human subjects research and IRB submissions. Appointments are appreciated, but walk-ins are welcome. To make an appointment contact the IRB Education Team.

IRB Administration Website

Not sure where to start with your human subjects research questions? Our website provides comprehensive information about human subjects protections and IRB review at UC Davis. You can find guidance on topics ranging from “Does my project need review by the IRB?” to “Collaborative research at UC Davis” and “Study closure submission process” and everything in between. Visit http://research.ucdavis.edu/irbadmin for more information.

IRB News Emails

When the IRB wants to highlight important news that may impact you we send out an IRB News email. You received this message because you have subscribed to IRB News. If you know someone who is new to UC Davis and could benefit from IRB News, they can subscribe by clicking here.

IRB Education Team

If you’ve looked high and low and still need more information, contact the IRB Education Team. We have a phone line and email account monitored by experienced staff here to help you.

Email: [email protected]
Phone: 916.703.9158

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Posted June 9, 2016

Announcing our Improved IRB Website with New Content!

After eight months of hard work, we are delighted to announce the launch of our new website on June 7, 2016. The site is available and the URL is http://research.ucdavis.edu/policiescompliance/irb-admin.

Our goal with this improved website is to provide our research community an easier way to locate information about the IRB, our submission process, and the federal, state and institutional regulations and policies that govern human subject research. New content has been added including such topics as:

• • • Does my project need review by the IRB?
    • How to Submit to the IRB
    • Student and/or Medical Resident Researchers Responsibilities
    • Faculty Advisor Responsibilities
    • Reporting to the IRB – What You Need to Know
    • Federal Educational Rights and Privacy Act (FERPA)
    • Recruiting Study Participants
    • Multi-site Collaborative Research

This is your website and we hope you find it offers easy access to the information you need. We welcome your feedback so that we can continue to improve the performance and content of our website. To provide feedback, please contact our Outreach, Training and Education Group at [email protected].

Articles of Interest

Botched French Drug Trial Followed Rules But Lacked ‘Common Sense’

France’s social affairs inspectorate said in report released May 21 that while the trial was legal, Bial and Biotrial made mistakes. Study participants were given a drug dose that was too high, the companies delayed alerting authorities, and Biotrial did not react quickly enough after the first participant got sick, the report said…..for the full article go here

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Posted May 10, 2016

Form Changes: The Continuing Review Progress Report (HRP-212)

To improve efficiency in routing studies for review and address problems reported by the research community we’ve made the following enhancements to HRP-212 Continuing Review Form:

• • • Included additional instructions for reporting vulnerable population enrollment numbers
    • Updated “Protocol Status” list with more detailed list of possible statuses
    • Reduced the number of questions pertaining to Related Financial Interest

We hope the result will address concerns raised by researchers and improve usability of the form.

Introducing the Continuing Review Committee

As a pilot program, we created the Continuing Review Committee to be dedicated to only review continuing review submissions for clinical/biomedical studies that are greater than minimal risk and have no modifications (except research personnel changes). This successful program has help reduce initial review turnaround times by allowing more initial review studies to be assigned to committee review quicker than in the past. The Continuing Review Committee meets federal regulations in its design and consists of members Committee A, Committee B and in-house reviewers that meets averagely once a month. For more information about the Continuing Review Committee contact our Education Group at [email protected].

IRB Office Hours

Need additional guidance or assistance with your IRBNet submission? Or, need to speak to us about your research? The IRB Administration’s IRB experts will be available every Tuesday (UCDMC Campus) and Wednesday (UCD Campus) at noon to provide one-on-one hands on help. You can make an appointment or just stop by. For more information about IRB Office Hours and location please visit our website at here.

Survey Opportunity: IRB Wants to Hear What You Have to Say!

The UC Davis IRB Administration would like feedback from the research community it serves on how we are doing. Please take a few minutes of your time and visit our survey at:

http://ucdavis.co1.qualtrics.com/SE/?SID=SV_6R922AhaROJa6Z7 (copy/paste link into browser)

OR

On our website at:

http://research.ucdavis.edu/feedback-form/

You may skip any questions you do not wish to answer. If you start the survey and find you do not wish to participate, simply exit the survey. We will receive your responses only if you click the “forward arrows” button at the bottom right corner of the screen.

If you are an IRB Committee member, please respond from the perspective of an IRB customer.

If you have any questions or concerns, please contact the UC Davis IRB Training and Education Group at [email protected].

Upcoming Events:

SoCRA Northern California Chapter Meeting

May 19, 2016 at 12 pm:

Best Practices in Clinical Trial Start Up

Presented by:

Kate Marusina, PhD, MBA

Manager, Clinical Trials Resource Group

&

Tracy Hysong

Project Manager/Budget Negotiations

Location:

University of California, Davis

Clinical Translational Science Center (CTSC)

2921 Stockton Blvd, Suite 1400, Room 1444

Sacramento, CA 95817

Parking and Entrance at rear of building

(Directions)

Objectives:

Introduce Clinical Trials Resource Group

Describe Start Up tools: process map, feasibility questionnaire, difficulty estimator, Microsoft project, templates

Describe Budget tools: internal template, negotiation with the sponsors

Put it all together!

1 CEU available to SoCRA members

Certificates of Attendance will be provided to those who attend

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Posted February 18, 2016

Research Personnel Changes to be Reported at Continuing Review

On March 14^th, 2016 the UC Davis IRB Administration will be breaking with tradition, but not any federal, state, local, or institutional law and/or regulation. The IRB is adjusting its requirement for reporting changes to research personnel lists. Going forward, please report all research personnel changes in submissions for continuing review. It is no longer necessary to submit a separate modification for each change in research personnel during a study; you can add and remove research personnel without submission of a new research personnel list (RPL) between initial and continuing reviews.

When onboarding new research personnel, Principle Investigators (PI) are still required to follow all federal, state, and local laws and regulations, as well as UC Davis policies and procedures. PI’s are required to:

• • • Verify the personnel are qualified to do the protocol procedures
    • Train the personnel on the protocol and procedures
    • Verify personnel are up-to-date on training in human subjects research
    • Report any conflict of interests among research personnel to the UCD Conflict of Interest Committee and the IRB.

Updated Standard Operating Procedures, Templates, Forms, Worksheets and Checklist will be made available on our IRB website prior to the March 14^th, 2016 effective date.

Please Note: changes to the PI and/or Co-PI do not fall under this new process. A modification must be submitted to the IRB prior to updating the PI and/or Co-PI of a protocol.

Please do not hesitate to contact the IRB Education Group with any questions at [email protected]. Do not reply to this email with your concerns or questions.

IRB Feedback Survey

The UC Davis IRB Administration would like to hear back from the research community it serves on how we are doing. Please take a few minutes of your time and visit our survey at:

http://ucdavis.co1.qualtrics.com/SE/?SID=SV_6R922AhaROJa6Z7 (copy/paste link into browser)

You may skip any questions you do not wish to answer. If you start the survey and find you do not wish to participate, simply exit the survey. We will receive your responses only if you click the “forward arrows” button at the bottom right corner of the screen.

If you are an IRB Committee member, please respond from the perspective of an IRB customer.

If you have any questions or concerns, please contact the UC Davis IRB Training and Education team at [email protected]. Do not reply to this email with your concerns or questions.

Updated Forms and Templates

The following minor changes have been made to the IRB documents listed below:

HRP-214 Reportable New Information:

• • • Number 10: updated to reflect only requests and/or inquiries from a federal agency to be reported.
      • Old language: “Audit, inspection, or inquiry by a federal agency or other entity and any resulting reports (e.g., FDA Form 483)”
      • New language: “Inquiry by a federal agency and any reports (e.g., FDA Form 483).”
    • Number 11: updated to include audit reports and clarify language.
      • Old language: “Ancillary approvals (e.g. CoC, SCRO) that do not result in a protocol revision, Data Safety Reports that include a recommendation to terminate or modify a study and written reports of study monitors with reportable events that have not yet been reported. “
      • New language: “Ancillary approvals (e.g. CoC, SCRO) that do not result in a protocol revision; written reports by study monitors and auditors that include reportable events that have not yet been reported; Data Safety Reports that include a recommendation to terminate or modify a study.”

HRP-212 Continuing Review Progress Report: added the underlined language to question ” Have subjects experienced any harms (unexpected or increased frequency and/or severity of expected) probably related to the research procedures.” The language was added to align with federal regulations serious adverse events reporting requirements.

HRP-213 Modification: removed the language “Point-by-point response (For a response to modifications to secure approval, deferral, or disapproval)”, as this form is no longer needed to respond to requests for revisions and/or a Letter of Action issued by the UC Davis IRB administration. Please note that the IRB requires a “PI Response Memo” providing a point-by-point response for any response to modifications to secure approval, deferral, or disapproval. These instructions are located within the form letters sent to the PI upon review by a convened board (i.e. full board review).

If you have any questions or concerns, please contact the UC Davis IRB Training and Education team at [email protected]. Do not reply to this email with your concerns or questions.

Upcoming Events:

San Francisco Bay Area SoCRA Chapter Meeting

Thursday, March 10^th, 2016 12 – 1pm

Medicare Coverage Analysis

Presented by:

Karen Mottola, MA, CHRC, CPC, CRCC
Research Compliance Officer, Sutter Health Systems Office

This presentation will be available via webinar at UC Davis

Location:

University of California, Davis Medical Center

Medical Education Building

4610 X St, Room 2205

Sacramento, CA, 95817

 

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Posted February 18, 2016

Great News for Researchers Using Online Web Services

Qualtrics Research Suite is now available to all UC Davis faculty, staff, and students through a campus-wide license.

Qualtrics is a web-based survey-tool similar to Survey Monkey and Survey Gizmo, but with advanced features designed for research in social sciences, marketing, and institutional analysis.

Some of the advance features include:

• • • Advanced logic, randomization, survey distribution, and panel management features needed for research in social sciences, institutional analysis, marketing, and other fields;
    • Analysis and reporting tools such as conjoint analysis, cross tabulation, graphical reporting, and downloading of data for external analysis in common formats including SPSS, CSV, XML, and more;
    • Robust collaboration that enables flexible sharing of surveys, responses, analyses, reports, question libraries, etc. both with other UC Davis users and with external collaborators;
    • A web API that enables integrating Qualtrics directly into your applications.

With campus-wide access, we believe that Qualtrics will be a valuable tool for research, teaching, and administration.

To access the UC Davis Qualtrics license log in at this address with your UC Davis credentials:

https://ucdavis.qualtrics.com/

To learn more about this service offering, including important links to institutional policies governing human subjects research, mass communications, and data security, please visit the entry for Qualtrics in the UC Davis IT service catalog:

http://itcatalog.ucdavis.edu/service/qualtrics-research-suite-online-surveys

Mechanical Turk Update

The University of California, Office of the President (UCOP) announced yesterday that the online service Mechanical Turk is acceptable to when conducting human subjects research if the data collected is non-sensitive. This information was provided to all UC IRB Administration Directors on February 16, 2016. Implementation of this announcement may vary with each UC IRB Administration.

UC Davis IRB Administration will not allow the use of Mechanical Turk if the data collected could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation, or is covered by HIPAA.

Prior to using and agreeing to Mechanical Turk terms and agreements, please contact UCD Contracting Service.

Please contact the UCD IRB Administration Education Group at 916-703-9158 or [email protected] with any IRB related questions.

IRBNet Quick Tips:

• • • Should I request the IRB unlock the package?

The IRB can unlock your current submitted package for editing/revising only when a determination has not been made on the submitted package. Reasons for researchers to request a package to be unlocked can be as follows:

• • • Missing documentation
    • New documentation
    • Errors in documentation
    • Wrong documentation

We often get requests to unlock a package so the researcher can submit a continuing review, modification, reportable new information or closure. These must be submitted as a new package.

To submit a new package to the IRB follow these steps:

• • 1. Enter your user name and password at irbnet.org
    2. Click the project title to open the protocol
    3. Click “Project History”
    4. Click “Create New Package”
    5. Click “Designer” and update documents, as appropriate
    6. Edit other project information, as appropriate
    7. Collect necessary signatures
    8. Click “Submit this Package” and complete the subsequent steps

DON’T FORGET TO CLICK SUBMIT!

The IRB cannot review your submission until you have

completed the steps to submit the package.

• • • Stacking Documents

“Stacking” is a convenient tool which allows you to quickly view the version history of one document in one simple click of the button. Not “stacking” documents causes delays in reviews and frustration for all parties involved. Thus, “stacking” is an important step to complete when submitting to the IRB.

To “stack” new documents on top of older versions:

• • 1. In the Designer, scroll the “Documents from Previous Packages” Section
    2. Click the pencil icon next to the document you wish to update
    3. Click “Choose File”
    4. Locate the file you wish to upload and click “Open”
    5. If appropriate, update the Description field
    6. Click “Update”
    7. The new version of the document is now “stacked” on top of the previous version of the document. Click the stack of papers icon to view a list of all versions of the document.
    8. Stack like documents; tracked-changes versions should be stacked on previously reviewed tracked-changes versions, while clean versions should be stacked on previously reviewed clean versions.

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Posted February 2, 2016

Amazon’s Mechanical Turk and Third Party Online Vendors

Important News for Researchers Using Online Web Services

From cloud hosting (e.g. Amazon Web Services) to online surveys (e.g. Survey Monkey) to smartphone applications (e.g. Apple: ResearchKit) the use of online web services is continually growing and so is their use in human subject research. With that growth comes the complication of online terms and conditions that can cause more harm than good for UCD and researchers. Faculty, student, or staff wishing to use online web services, for research or not, should check with UCD Contracting Services prior to agreeing to any contracts and/or online terms and conditions. Their website also provides a list of online web services that have been “pre-approved” by UCD for use. UC Davis is working to obtain a contract with another survey vendor, Qualtrics. More information on this vendor should be coming soon.

University of California, Office of the President has stated that the use of Amazon’s Mechanical Turk for research is not permissible. The two most poignant reasons for UCOP’s ban on the use of Mechanical Turk is due to the site not providing adequate privacy provisions and Mechanical Turk’s claim to co-own all data transmitted on their site. In response, the UCD IRB Administration will no longer approve initial application submissions in which Mechanical Turk is used. Existing IRB approve protocols, that are utilizing Mechanical Turk, will be grandfathered and not be required to change to another online web service.

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Posted December 21, 2015

IRBNet’s Online Initial Review Application (New Project)

As of January 1, 2016 all New Projects must contain (at minimum) the following:

• • 1. Online Initial Review Application
    2. A sponsor protocol OR an abbreviated HRP 503 Protocol (see next article)
    3. HRP 226 Administrative Approval Form
    4. Electronic signature of the Principal Investigator

Many studies will require additional documents such as a consent form and other documents provided to participants. When the electronic Initial Review Application form is completed, a “Form Complete” page will appear, and this page will include a list of additional documents required for the study. This list will be based on the information you entered on the electronic application.

IRB Administration will soon be removing the following from IRBNet’s Forms and Templates section as well as the IRB Administration’s Forms Page, as these documents have been replaced by an online form or by an abbreviated version of the previous document described in the section below.

• • • HRP 211 Application for Initial Review
    • HRP-503 Protocol Template Standard
    • HRP-503 Protocol Template Research Involving Retrospective/Prospective Data Specimen Review
    • HRP-503 Protocol Template Research Involving Surveys/Questionnaires/Interviews and/or Focus Groups
    • Qualifying Clinical Trials Form

Abbreviated HRP-503 Protocol Templates

IRB Administration has developed abbreviated versions of the HRP 503 Protocol Template to be used in conjunction with the online Initial Review Application when there is no sponsor protocol. These templates have been tailored to eliminate redundancy and provide standardized answers whenever possible. IRB Administration’s goal is collect all information necessary to ensure compliance and protect the rights and welfare of human subjects and reduce the need to request additional information from researchers.

Three abbreviated protocol templates have been created; one for general use and two for specific types of research. You only need to submit one Protocol with your New Project and should select the template most appropriate for your research.

• • • HRP-503 Protocol Template *Use with online Initial Review Application Form
    • HRP-503 Record/Data/Specimen Review Template *Use with online Initial Review Application Form
    • HRP-503 Surveys/Interviews and/or Focus Groups Review Template *Use with online Initial Review Application Form

Introducing UC Davis IRBNet Demonstration Videos

IRB Administration has created several IRBNet demonstration videos covering a range of topics. The videos are specific to the UC Davis IRBNet submission process and provide step-by-step guidance for UC Davis Researchers. Click a here to view the videos.

• • • Create New Project (Initial Review of a New Study)
    • Create New Package (Response to a Letter of Action, Modification, Continuing Review or Reportable New Information)
    • Package Unlocked, Project Mail Response
    • Sharing a Project
    • Electronic Signature
    • Stacking Documents

IRBNet Tip:

Corresponding with the IRB Administration

During the review process you may need to send and/or reply to a correspondence from IRB Administration. You must use the Project Mail feature within IRBNet for all communications related to your project. You can access this feature by logging into IRBNet, clicking the project title, and clicking “Send Project Mail.”

If you need to send correspondence to the IRB Administration and you are unsure who to contact, please send the message to Royce Yokoi only and he will forward your message to the appropriate person. Do not select all IRB Administration staff, as this selection will delay responses to your inquiry.

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Posted November 30, 2015

IRBNet’s Initial Review Application

IRBNet has an efficient way of submitting new applications to the IRB using a “Smart Form” online application. This electronic form is an efficient, user friendly way to submit an application that replaces all of the following:

• • • HRP-211 Application for Initial Review
    • HRP-215 Research Personnel
    • HRP-503 Protocol Template when a sponsor protocol is submitted, and
    • Project Information Worksheet.

In other words, you do not need to submit any of the above if you complete and submit an online application.

The online application is easy to complete because the form will ask questions based on answers to previous questions. So, it will not ask for information that is not applicable to your submission.

Effective January 1^st, 2016, all initial review applications submitted will be required to utilize the IRBNet online Initial Review Application form. To learn more about the benefits of the online Initial Review Application form and IRBNet, please visit our website here.

IRBNet Tip:

What is “stacking” and why is it so important?

“Stacking” is uploading a new version of a document within the same file that a current previously reviewed version exists. Stacking is similar to filing new versions of documents in an electronic folder in chronological order with the most recent version on top. IRBNet is an electronic database that is compliant with federal regulations. Regulators will look at documents in IRBNet to insure the IRB and investigators have communicated when required and all documents (and versions of documents) required by regulations are maintained. Stacking provides “version control” functionality that ensures the requirements are satisfied.

Please be sure to stack all documents, if applicable, appropriately prior to submitting the package to the IRB for review. IRB will request that you correct your submission if the documents are not stacked appropriately. To stack documents follow these quick and easy steps:

• • 1. Click the pencil icon next to the document you wish to update
    2. Click “Choose File”
    3. Locate the file you wish to upload and click “Open”
    4. If appropriate, update the Description field
    5. Click “Update”
    6. The new version of the document is now “stacked” on top of the previous version of the document. Click the stack of papers icon to view a list of all versions of the document.
    7. Stack like documents; tracked-changes versions should be stacked on previously reviewed tracked-changes versions, while clean versions should be stacked on previously reviewed clean versions.

To learn more about stacking and more, please visit our website here.

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Posted October 31, 2015

IRBNet Rollout – FINAL NOTICE

November 2, 2015 is the IRBNet Transition Deadline

As of November 2, 2015 all submissions to the IRB must be made through IRBNet. The IRB Administration will no longer accept any submissions via eDocuments and IRB accounts will be removed from the eDocuments system. If you have not prepared for the transition, please visit our website at http://research.ucdavis.edu/irbnet/ to learn how to register an IRBNet account, access training resources, and request the release of your existing IRB studies.

One-on-One IRBNet Support

Need assistance with your IRBNet submission? The IRB Education Team will be available every Tuesday at noon to provide one-on-one assistance; you ca make an appointment or just stop by. For more information about IRBNet Lab hours and locations please visit our website athttp://research.ucdavis.edu/irbnet/#IRBNet Training.

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Posted October 21, 2015

IRBNet Lab Available

10 Days until IRBNet Completely Replaces eDocuments

Starting November 2, 2015 all IRB submissions must be made through IRBNet. The IRB Administration will no longer accept any submissions via eDocuments and IRB accounts will be removed from the eDocuments system. If you have not prepared for the transition, please visit our website at http://research.ucdavis.edu/irbnet/ to learn how to register an IRBNet account, access training resources, and request the release of your existing IRB studies.

*NEW* IRBNet Lab Hours

Need additional guidance or assistance with your IRBNet submission? The IRB Administration’s IRBNet experts will be available every Tuesday at noon to provide one-on-one hands on help. You can make an appointment or just stop by. For more information about IRBNet Lab hours and location please visit our website at http://research.ucdavis.edu/irbnet/#IRBNet Training

*NEW* Protocol Template for Surveys/ Interviews/Focus Groups

We now have a protocol template (HRP-503) specifically for research involving interviews, surveys, and focus groups. This new template is designed to collect all of the information the IRB needs to make a determination. Our goal is to reduce the review time for these studies by eliminating the need to contact researchers requesting additional information. We encourage you to use this template for all research involving surveys, interviews and/or focus groups. To download the template, please visit our site at http://research.ucdavis.edu/irb-forms/.

SoCRA Chapter Meeting Thursday, October 22, 2015

Time: 12:00 PM – 1:00 PM

Location: UC Davis Medical Center Education Building Room 3204

4610 X Street, Sacramento, CA 95817 http://www.ucdmc.ucdavis.edu/healthconsumers/calendar/Education_Building_map.html

Topic: HIPAA Privacy Rule

Speaker: Sharalyn Reed, JD, MPH, CHC, Deputy Compliance Office, UC Davis Health

Program Objectives: At the conclusion of the program, attendees should be able to:

• • 1. Explain how the Rule affects investigators’ ability to conduct research
    2. Explain the requirements that must be met before an individual’s protected health information can be accessed for research purposes
    3. Explain the rights individuals have to access, amend and amend their medical record
    4. Explain the institution’s requirement for accounting for disclosures

For more Information, contact:

Daniel Redline, BA, CCRP, CIP (Chair)

[email protected]

Lori Ried, RN, CCRP (Vice Chair)

[email protected]

Cindy Gates, JD, RN, CIP (Outreach & Education Officer)

[email protected]

Cost: Free – All SoCRA members and nonmembers are welcome.

SOCRA Members receive 1.0 continuing education unit for attending.

Remote attendance is available through WebEx if there are at least 2 SoCRA members at the Remote Site. Please email Liza Reys, Chair of the SF Bay Area Chapter, at [email protected] for details.

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Posted October 12, 2015

IRBNet Final Phase Nov. 2

Important: On November 2 eDocs will no longer be available and you must use IRBNet for all submissions.

After several months of phased implementation the final deadline to transition to IRBNet is nearly here. Soon IRBNet will be fully launched to UC Davis and we will wave goodbye to the eDocuments System. Starting November 2, 2015 all IRB submissions must be made through IRBNet. The IRB Administration will no longer accept any submissions via eDocuments and IRB accounts will be removed from the eDocuments system. If you have not prepared for the transition, please visit our website at http://research.ucdavis.edu/irbnet/ to learn how to register an IRBNet account and request the release of your existing IRB studies.

*NEW* IRB Office Hours

The IRB Administration is now hosting lunchtime office hours to answer your questions about human subjects research, IRB requirements and submission processes. You can make an appointment or just stop by. For information on dates, times, and location please visit our website at http://research.ucdavis.edu/irbnet/#IRBNet Training

*NEW* IRBNet Quick Tip

As you know, the UC Davis IRB can only have quick turnaround times if we know a researcher has uploaded new or revised documents into IRBNet.. To be sure our office receives the proper notification, please click on the “mark revisions complete” link in the top left hand corner of the Designer page once the documents have been updated. This changes the red unlock symbol to a green lock and notifies us you have completed revisions.

To learn more about ways to save your time with IRBNet visit our FAQ section of our IRBNet website at http://research.ucdavis.edu/irbnet.

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Posted September 9, 2015

Urgent IRBNet News

Have You Created an IRBNet Account Yet?

If not, you will soon be unable to submit to the IRB. For step-by-step account-creation instructions click here.

Have You Requested Access to Your Existing Studies Yet?

If not, time is running out. After September 14 all Continuing Review submissions must be made through IRBNet.

You must email the IRB Education Team and request that your studies are released. Do not create a new project when submitting for an existing study. For more information about requesting access to your existing studies click here.

Once the study release is complete you will see your protocols when you log into IRBNet. You and your research team will use IRBNet for all future IRB submissions.

IRBNet training is available via online and/or in classroom. Classes are being held weekly every Wednesday. For more information about IRBNet training, please visit our website here.

Ten Reasons to Create your IRBNet Account Now:

• • 1. All submissions must be through IRBNet beginning November 2.
    9. It takes less than 5 Minutes to create an account.
    8. The IRBNet online Initial Application Smart Form is the fastest and easiest way to create a new study.
    7. You can access your IRBNet account to upload, sign and view documents wherever there is Internet.
    6. IRBNet is a repository for all of your IRB documents.
    5. You never have to find the investigator to obtain a signature. Wherever there is Internet, the PI can sign.

4. You can track the review process in real time.

• • 3. You can sync your CITI account with IRBNet so you will know when training is required.
    2. Submitting through IRBNet speeds up the review process.
    1. Submitting through IRBNet reduces the workload for everyone!

IRBNet TIPS

Project Status View: Submission Manager Enhancement

On the top of the My Projects table, to the left to the “Collapse by Project” link, you will find the new “Project Status View” link. Clicking this link will reveal the most recent Project Expiration Date and Project Status for each submission. This information will be displayed for all submissions shown. Uses include:

• • • Prioritize Continuing Review submissions according to Expiration Date.
    • Combine “Project Status View” with “Collapse By Project” to view projects according to Project Status.

Tagging Your Projects

Use Tags to organize your projects, track tasks and status, and share important information with other users. When you tag a project you can choose if you want to keep the Tag personal (only you can see it) or if you want to share the Tag so it can also be seen by others (note that you can only share your Tags if you have Full or Write access to the project). For example:

• • • Add a Tag to remind your PI to sign the new package waiting for submission
    • Add a Tag to remind your PI of the IRB administrative due dates for renewals
    • Add a Tag to identify protocols that are Clinical Trials
    • Add a Tag to identify sponsored protocols

Replying to IRBNet Messages

Messages sent from IRBNet are being forwarded to the email address on file in your account profile. Please keep in mind to reply to this message you need to log into IRBNet and use the “Send Project Mail” feature to respond. DO NOT REPLY DIRECTLY TO THE EMAIL. This is the only way IRBNet will be able to capture and archive communication between the researcher and IRB.

Note: Federal regulations require that all communication between researchers and the IRB, in regards to a specific protocol under review, be kept on file with the protocol. This requirement applies to the IRB and the researcher. IRBNet was designed to do this for both parties by storing the communications in one location that all have access to. This feature only works if it is used properly by both parties.

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Posted August 19, 2015

IRBNet Stage 1 Launch a Go!

You’ve trained on IRBNet. You’ve activated your IRBNet account. You’ve integrated your CITI account. Now you’re ready to use this awesome new online electronic database. As of August 17^th all initial review submissions are required to be submitted via IRBNet. Initial applications submitted through eDocuments will be rejected with instructions on how to setup an IRBNet account. At this time, we are not requiring researchers to use IRBNet’s Online Initial Review Application (although we think you’ll find it much easier to use than the old HRP-211 Application for Initial Review). For the time being, we are still accepting HRP-211 Application for Initial Review, with supporting documentation, when submitted via IRBNet. To improve on IRBNet’s functionality as a “one stop shop” electronic database for submitters we have added our forms and templates into IRBNet’s Library. The following documents are now located within the “Forms and Templates” section of IRBNet:

• • • Form: HRP-211 Application For Initial Review
    • Template: HRP-502 Informed Consent
    • Template: HRP-503 Protocol
    • Template: HRP-503 Research Involving Record/Data/Specimens Review
    • Template: HRP-504 Letter For School Permission To Conduct Research

Be prepared for the next stages:

• • • Stage 2: September 14 – You will need to submit all continuing review submissions through IRBNet.
    • Stage 3: November2 – You will need to submit all submissions through IRBNet.

ONGOING: ALL PRINCIPAL INVESTIGATORS, CO-PRINCIPAL INVESTIGATORS, AND PRIMARY CONTACT PERSONNEL ARE REQURIED TO CREATE AN IRBNET ACCOUNT FOR RELEASE OF EXISTING STUDIES

IRBNet Training Available Online or in Classroom

Learn more about IRBNet by taking an online course and/or reserve a seat in a classroom. For more information about IRBNet training, please visit our website here.

For further information about IRBNet, please visit our website at http://research.ucdavis.edu/irbnet.

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Posted August 5, 2015

New Submission Requirements Starting August 17^th

Out with the old, in with the new! As you may recall from last month’s announcement, the IRB Administration has successfully field tested IRBNet in preparation for its release to the research community. We are now ready to roll IRBNet out in stages to the community to smooth the transition between systems. The stages will occur as follows:

• • • Stage I: August 17 – You will need to submit all initial review submissions through IRBNet.
    • Stage 2: September 14 – You will need to submit all continuing review submissions through IRBNet.
    • Stage 3: November 2 – You will need to submit all submissions through IRBNet.

For those not familiar with IRBNet, here is a brief summary: IRBNet is a researcher-facing database that contains a robust set of electronic tools supporting the management, submission, review and oversight of research protocols. Some of the many features include an online initial application, electronic document management, web-based protocol sharing and collaboration, automatic notifications, electronic submissions and reviews, integrated training and credential management, and important audit capabilities including electronic revision histories, electronic signatures and event tracking.

IRBNet training is available via online and/or in classroom. For more information about IRBNet training, please visit our website here.

For general information about IRBNet, please visit our website at http://research.ucdavis.edu/irbnet.

More information on Exemption Category 4 and Medical Record Review

Last month, we reported that we would start applying exemption Category 4, research involving the use of existing data, to protocols that involve retrospective medical review as the primary activity. To qualify for this exemption, the following must be true:

“Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects”

In layman terms, when you record data from the medical record you cannot record any individually identifiable information. In addition, you cannot use a coding system to link the information back to an identifier for future reference. In other words, the recorded data must be completely anonymous. However, limited data sets are considered “not individually identifiable” and qualify for this exemption. See our HIPAA Guidance webpage for additional information on what is considered identifiable data.

Please be aware, approval of research for retrospective chart review will cover only records that already exist at the time of initial submission to the IRB. If you believe that you might need to later revise your study to obtain information from medical records that will be completed in the future (but are existing at the time of the revision), you should consider including the procedures in the initial submission and obtaining prospective consent from those patients about whom medical record data will be generated. We are unlikely to approve modifications to studies that keep extending the data range of records to be reviewed unless the modification includes a plan to obtain consent and authorization from the patients. UC Davis IRB is committed to follow the ethical principle of Respect for Persons, which means we will obtain prospective consent and HIPAA authorization from subjects if we contemplate the need to use their information for research purposes.

If you have any questions about this topic, please contact our Outreach, Training and Education team.

OHRP Education Workshop, October 14^th

OHRP is hosting an education workshop for research investigators and coordinators relatively new to human subjects research.

The Office for Human Research Protections (OHRP) co-hosts with

The Office of Extramural Research (OER) at the National Institutes of Health

A one-day pre-seminar workshop

“Getting through Human Research Reviews with Skill”

On Wednesday October 14, 2015

At the 2015 NIH Regional Seminar, Hilton San Diego Bayfront in San Diego, California

This workshop aims to provide participants with the skill and knowledge necessary to have their NIH grant applications and research protocols pass reviews for human research protections. It will focus on clarifying confusions and providing participants with practical tips and solutions to problems and difficulty commonly encountered during such reviews.

This activity has been approved for 5.75 AMA PRA Category 1 Credit™

REGISTER NOW at http://regionalseminars.od.nih.gov/sandiego2015/sessions/00a/ if you answer YES to any of the following questions:

• • • Do you feel quite baffled by the different requirements on human research protections and wondered how you could get ahead of the process?
    • Are you sometimes confused when a research using data collected from human participants is considered ‘human subjects research’ and when it is not?
    • Have you ever felt frustrated with being told that you had not included adequate protections for human participants, when you had already spent hours working on the proposal?

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Posted July 10, 2015

Changes to reduce administrative burden

The UC Davis IRB is always looking for ways to reduce administrative burden on researchers, IRB Members and IRB Staff. We are pleased to announce several changes in our procedures that should have this effect.

(1) Exemption Category 7

First, we have created a new Exemption Category for some minimal risk studies that do not quite fit within the categories existing under the regulations.

“Exempt Studies” are studies that are not covered by the regulations found in the Common Rule. Exempt studies do not require continuing IRB oversight, so you need have limited contact with the IRB after approval. In fact, the only time you need to contact the IRB about an exemption is to obtain the exemption determination before study start and to submit protocol revisions so we can determine if the changes cause the study to no longer qualify for exemption. You do not have to send updated research personal lists for exempt studies.

Exemption Category 7 is available only for studies that are not funded or supported by the federal government. The study must also involve only minimal risk and must not include any physically invasive interactions. Exemption 7 includes studies that are not federally funded or supported and are limited to activities such as:

• • • Reading/writing/drawing tasks.
    • Physical activities such as walking, sitting, or manipulating an object.
    • Computer tasks and/or Internet searches
    • Talking and/or listening to words, then making selections, or “think-aloud” exercises.
    • Viewing media
    • Role-playing.
    • Completing a specific physical or mental action (“imagining”).
    • Passive monitoring of space (environment) with sensors.
    • Playing a game.
    • Height/weight measurements.

To obtain an exemption determination, please submit the usual documents to the IRB (HRP 211 Application for Initial Review; HRP 226 Administrative Approvals; and HRP 503 Protocol Template or Protocol Template for Research Involving Record/Data Review. If your study includes interactions or interventions with participants, you will need to submit consent language that includes:

• • • A statement that the project is research;
    • A description of the procedures;
    • A statement that participation is voluntary; and
    • The PI’s name, association with UC Davis and contact information.

We will begin to immediately apply the criteria for Exemption 7 to new initial applications. Current approved protocols may qualify for Exemption 7, which will be determined at next renewal.

(3) Extended application of Exemption Category 4

In the past, the IRB has not included research that involves retrospective review of medical records as exempt under Category 4, research involving the use of existing data. Instead, we elevated the review requirements to the expedited review level, which involves additional administrative burden on behalf of the investigator and the IRB.

We recently researched how other IRBs apply this exemption when retrospective medical record review is the primary activity, and found that this exemption is routinely applied. We will now include these types of studies under this exemption. We will waive the requirements for HIPAA Authorization for this type of research whenever the requirements for the wavier are met.

Please be aware, approval of research for retrospective chart review will cover only records that already exist at the time of initial submission to the IRB. If you believe that you might need to later revise your study to obtain information from medical records that will be completed in the future (but are existing at the time of the revision), you should consider including the procedures in the initial submission and obtaining prospective consent from those patients about whom medical record data will be generated. UC Davis IRB is committed to follow the ethical principle of Respect for Persons, which means we will obtain prospective consent and HIPAA authorization from subjects if we contemplate the need to use their information for research purposes.

(3) Revised Deviation Reporting Timelines

Next, to reduce administration burden, the IRB has revised the policy for reporting deviations from the protocol, regulations and IRB requirements. In the past, investigators were required to report deviations within five business days of learning about the deviation. The procedure has been revised to allow for a ten-day deadline for these reports. This revision is documented in our FORM: HRP-214 Report of New Information.

Please note that reports of new risk information must be reported within five business days. Risk information includes serious adverse events that are both unexpected and related to the study, revised investigator brochures with new or revised risk information, sponsor letters to investigators advising of new risks, etc.

HIPAA Accounting for Disclosures

The Federal Privacy Rule (HIPAA) requires University of California, Davis Health (UCDHS) to maintain records of access to protected health information (PHI) for research activities (1) preparatory to research, (2) through a waiver of authorization; and (3) involving decedent’ PHI. UCDHS must provide information about those disclosures upon request of the patient or their legally authorized representative. All such access must be documented by accessing the Tracking and Disclosure database.

Recording a disclosure of access to patient records may be documented in one of two ways:

(1) Quick Disclosure Activity in EMR – Please see P&P 2446 for instructions or contact research compliance for a quick demonstration at: [email protected]

(2) Disclosure Tracking Database: https://disclose.ucdmc.ucdavis.edu/ or by typing “disclose” into the UCDMC intranet web browser.

For more information, go to http://www.ucdmc.ucdavis.edu/compliance/guidance/research/researchprivacy.html. Alternatively, questions/training on HIPAA accounting, please contact the Compliance Program at [email protected].

IRBNet Update and Training Opportunities

Back in April, we announced the testing of our new electronic database system, IRBNet, and offered in-person training for departments/divisions willing to take the first step into IRBNet. Testing has been completed successfully and we would like to thank the individuals in the 18 departments/divisions for volunteering and their valuable feedback.

We are now in final preparation for launching IRBNet to the research community; the official launch date has yet to be determined. In the meantime, our Training and Education group would like to extend the offer of in-person training classes to all department/divisions. Classes are being held once a week thru the month of August.

Do not delay, space is limited and classes fill up quickly and we will no longer begin to accept submission through eDOCs sometime this fall. Please contact our Training and Education Analysts for more information and reservations:

Nicole Walters [email protected]

Miles McFann [email protected]

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Posted April 7, 2015

New IRB Electronic Database

We are happy to announce that we are launching IRBNet to the research community early this summer.

Since 2011, the UC Davis IRB Administration has been using a web-based system called IRBNet to administratively process the review all submissions sent to our office. As part of our process, we have been creating a submission and uploading the documents you send through eDocs into the IRBNet system.

With this launch, you will have direct access to IRBNet and will upload your own submissions directly into this web based system. You will also be able to manage, modify and track your submissions through this system. In fact, this transition will allow you to:

• • • Access to your submissions anytime and anywhere Internet access is available
    • Use an online questionnaire to automatically complete an Initial Review Application Form, which will streamline the submission process
    • Use electronic signatures instead of pen and paper signatures whenever Internet access is available
    • Receive real-time notifications of changes in submission status
    • Use the system for electronic storage for IRB correspondence and for all documents reviewed and approved by the IRB

One more advantage, is that you will no longer need to submit an HRP Form 503, Description of Study, when you use the new electronic Initial Review Application Form and submit a sponsor protocol.

These past months we’ve been testing IRBNet with principal investigators and coordinators to prepare for this launch. Now we’ll begin a pre-launch rollout of the system by offering departments (UCD or UCDMC) a chance to switch to IRBNet prior to the launch date. We are looking for departments that are willing to commit, as a group, to receive IRBNet training and transition to IRBNet two weeks after training. If your department wants to participate in this pre-launch phase, you will need to schedule your department for training on the IRBNet system. To schedule an appointment, please contact our Training, Education and Outreach team:

• • • Nicole Walters at [email protected]
    • Miles McFann at [email protected]

We are not accepting individual requests for pre-launch training and transition. If you are not part of a department that chooses to obtain the training, we ask that you refrain from using IRBNet on your own until you are invited to do so. We need to roll the system out slowly because there is a significant amount of work we have to do in the background each time an investigator access the system for the first time. If too many investigators initiate their first access at the same time, the additional background work will negatively impact on our ability to complete reviews and result in delays.

Until you receive log-in instructions for IRBNet from us, please continue to use our eDocuments system for all submissions (i.e. Initial Reviews, Continuing Review, Modifications and Reportable New Information).

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Posted March 23, 2015

New Law Impacting Newborn Research

The Newborn Screening Saves Lives Reauthorization Act of 2014 (HR 1218) went into effect on March 16, 2015 and applies to blood samples obtained for federally mandated newborn screening tests.

The law requires the regulations for human research (45 CFR 46) to apply to research with newborn screening blood spots whenever the research is funded by the Public Health Service Act. As currently written, 45 CFR 46 excludes use of newborn screening bloodspots because the use is not considered human subjects research. This new law takes priority over the current regulation. Second, the law eliminates the ability of the IRB to waive informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots.

The law was enacted December 18, 2014 and took effect March 16, 2015. Submissions for IRB review on newborn screening research will follow the current review process. For more information about the review process refer to our Investigator Manual.

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Posted February 2, 2015

Change to Administrative Due Date

We are pleased to announce that we are reducing the administrative due date for protocol renewals and closures from 60 days prior to study expiration to 45 days prior to study expiration. This change will be effective on February 4, 2015, and will appear on approval letters issued on and after February 4.

This change will have no impact on submissions already received by our office. These submissions will be reviewed according to the previous schedule. Our online forms have been updated to reflect this change. We will accept the older versions of the form until March 5, 2015. The IRB will not accept the older version of the forms after this date.

In addition, the courtesy renewal reminder notices will no longer be issued at 90 days prior to expiration. Instead, the notices will be sent out 60 days prior to expiration. Going forward, courtesy reminders will be sent according to the following schedule:

• • • 60 days from protocol expiration
    • 30 days from protocol expiration*
    • On or after protocol expiration date**

*The IRB will require the principal investigator (PI) to submit a corrective and preventive action plan to address late submissions of Continuing Review Progress Reports (HRP-212) within the 45 day due date. This plan should outline the actions that will be taken to ensure future reports are submitted on or before the due date.

**The IRB will restrict PIs from submitting new protocols for review whenever approval of a protocol terminates because of the PIs failure to submit the HRP-212 progress report prior to the expiration date. The PI will remain on the restricted list until the issue is resolved.

Please note that submissions received more than 90 days before the protocol expiration date will be rejected.

Principal investigators should not rely on the IRB’s courtesy reminders as the only means of meeting submission timelines. Instead, PIs and research staff should create their own personalized notification system to ensure that reports are submitted before the administrative due date.

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Posted October 9, 2014

AAHRPP ACCREDITATION VISIT

JANUARY 5-7, 2015

The University of California, Davis is in the final stages of receiving institutional accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). This organization accredits high-quality human research protection programs in order to promote excellent, ethically sound research.

As part of the accreditation process AAHRPP members will be visiting our campuses January 5 – 7 to assess UCD’s Human Research Protection Program. The site visit will include interviews with faculty and staff who are engaged in human subject research. Individuals to be interviewed will be chosen by AAHRPP in early November. As soon as we receive the list of individuals to be interviewed, UCD’s IRB Administration staff will contact those selected to schedule a one-hour training and interview preparation session.

If you have any questions about this accreditation process, please contact Kathryn Smith at 530-304-8051.

Starting a new chart review study?

Try our new Retrospective/Prospective Data Review Protocol Template

Using our template will save time, reduce the number of questions we ask you and reduce the number of questions you have for us. You can find the template at: Protocol Template – Retrospective/Prospective Data Review.

We have taken away the head scratching and guessing and have, instead, provided you with a way to include all of the information you need to include in your protocol through questions and answers.

Sample:

Indicate if this is a retrospective and/or prospective chart/data review:

☐ Retrospective Chart/Data Review (Retrospective means the data you will access are already in existence when the project is submitted to the IRB for initial review)

When were these data collected by the source?

From Month/Year to Month/Year

☐ Prospective Chart/Data Review (Prospective means the data you will access are not in existence when the project is submitted to the IRB for initial review)

When will these data be collected by the source?

From Month/Year to Month/Year

This simplified form is a win for both you and the IRB. It decreases the amount of time you spend filling out the form and decreases the amount of time the IRB spends on reviewing the form.

If you have any questions about the new template, please contact Miles McFann.

Tips: Documents the IRB Does Not Need

Often our office receives additional documentation that is not required for us to conduct our review. Please only submit documentation that is outlined on our HRP-211 – Application for Initial Review.

Below is a sample of forms we do not need to review:

• • • HIPAA Authorization Form for Research (UCDMC Approved Form)
    • Self – Certification of Surrogate Makers for Potential Subject’s Participation in University of California Research (UC Approved Form)
    • IRB Worksheets
    • IRB Checklists

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Posted September 10, 2014

Notice: Using Electronic Signatures on IRB Forms

Please note: As a Principal Investigator, if you allow your staff to apply an electronic signature to a form submitted to the IRB, you are responsible for ensuring the form is accurate. You should have procedures in place to ensure you review these forms before they are submitted.

Requirements for Institutional Biosafety Committee (IBC) Review

As a reminder, the UC Davis Institutional Biosafety Committee (IBC) provides oversight of campus and UCDHS research, teaching, and related activities that involve recombinant DNA technology, infectious agents, and other biohazardous materials (e.g. materials that fall under the Bloodborne Pathogens Standard). The IBC assesses each project, determines the appropriate containment (biosafety) level, and approves these activities through the Biological Use Authorization (BUA) process. The IBC membership and business activities conform to the requirements of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The Vice Chancellor for Campus Planning, Facilities, and Safety appoints IBC members and provides staff support to the IBC. If you would like more information on BUAs, please visit this website (http://safetyservices.ucdavis.edu/ps/bis/f_p/bua/bioUseAuthorization_BUA) or contact the Biosafety Office ([email protected]).

Faculty Still Needed: Chancellor Requests Feedback on Research Compliance Infrastructure

Chancellor Linda Katehi has commissioned an external assessment of research compliance and integrity at UC Davis. To this end, on October 13-15, 2014 we will host a team of five nationally recognized research administrators on campus conducting a peer review of our research compliance structures as part of the National Council of University Research Administrators (NCURA) peer review program. This review, similar in nature to an academic program review, is being done to ensure that we are appropriately organized to advance excellence in research and ensure the ethical conduct of research while also encouraging creative accomplishments with the UC Davis community.

The site visit in October provides an opportunity for the NCURA peer reviewers to interact with representatives of important constituent groups in the UC Davis research community. The NCURA peer review team would like to meet established faculty and junior faculty (faculty with 3-5 years of independent research) whose research requires oversight by one or more research compliance committees (IRB, IBC, COI, SCROC, HASTOC, etc).

The NCURA group has requested two sessions of up to 20 faculty researchers (one for established faculty and one for junior faculty). As such, the following times have been established for this purpose.

Wednesday, October 15, 2014 – location Alumni Center, Founder’s Board Room

Established Faculty Session: 1-1:30 pm

Junior Faculty Session: 2:30-3:15 pm

Please confirm your availability to participate as soon as possible by email to Compliance Analyst Larisa King ([email protected]; 530-752-6550).

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Posted September 2, 2014

IMPORTANT NOTICE

We recently updated the Human Research Protection Program Plan,

the Investigator Manual, and many of our SOPs.

We also updated most of our forms.

Please read the revised Plan and Manual.

Please download the forms from our website for new submissions.

Updated Submission Forms

This past week we released a multitude of revised documents (e.g. Forms, Templates, Checklists, etc.) on our website in response to AAHRPP’s requested changes as part of our Step 1 and Step 2 applications for accreditation. Most of the changes are minor. However, the Human Research Protection Program Plan, the Investigator Manual, and three forms have important revisions (HRP-212, HRP-213 and HRP-507).

The Continuing Review Progress Report (HRP-212) form now includes two new fields:

• • • A new field has been added to capture information about modifications, revisions, or changes made to the research without first obtaining approval. The IRB is required to have procedures in place to ensure that changes to research are not implemented without IRB approval, unless the change is required to protect a participant from an immediate hazard. If you did not make any unapproved changes to your research, you need only check the “No” box. However, if you made unapproved changes to the research, you will need to complete additional forms to provide information about the change(s).
    • A new field has been added to address the IRB’s requirement for you to submit your plan to comply with the IRB’s reporting requirements whenever you submit the continuing review progress report after the due date. Before this revision, you were required to submit an additional form (HRP-214) to describe your reasons for submitting the report late and to describe your plan to ensure you submit future reports before the due date. This revised form captures the same information as the HRP-214 form, so you no longer need to complete that additional form. If you submit your report to the IRB on time, you need only mark “No” in the first box of this new field. If you submit the report after the due date, you need to complete the remaining fields in the section.

The Modification (HRP-213) form now includes:

• • • A new field to quickly identify when a modification involves new foreseeable risk information. The new field also captures information that will help the IRB determine whether the plan for notifying participants about the new risk information is sufficient. Previously we requested investigators to submit a Reportable New Information (HRP 214) form whenever a modification included new foreseeable risk information. This revision replaces the need for the additional form HRP 214.

The updated Informed Consent Short Form (HRP-507) now includes fields for investigator contact information. You must include this information before using the form.

These revisions were designed to reduce the number of forms that need to be submitted while increasing everyone’s ability to remain compliant with standard operating procedures, UCD policies, state law and federal regulations. To reduce your workload, please start using the new version of the forms today. The IRB will no longer accept outdated versions of these forms after November 3, 2014; only the newer version will be accepted.

Tip: Using the Updated Informed Consent Short Form

Since we work in a fast-paced environment, it is not always convenient to complete the form after a potential non-English speaking participant is identified. We recommend completing these forms in advance so you will have a “ready to use” copy of each translation of this form.

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Posted August 19, 2014

Informed Consent Short Form

In our continuous efforts to increase efficiency and consistency, the IRB Administration updated our short form (Informed Consent (HRP-507) so that it is similar in design, formatting and wording with our Informed Consent (HRP-502). The new short form will include the experimental bill of rights, updated boilerplate language, and new signature blocks (i.e. assenting children and cognitively impaired). The form will be available in the following languages; Vietnamese, Chinese, Hmong, Russian and Spanish.

The forms will be posted to our website on August 15, 2014.

An IRB gentle reminder, whenever you need to use the short form Informed Consent (HRP-507), you must follow the regulations and UC Davis policies. It important that you review our Standard Operating Procedure Informed Consent Process for Research (HRP-090) and Standard Operating Procedure Written Documentation of Consent (HRP-091) to ensure that you conduct the consent process and document consent in compliant manner.

Chancellor Requests Feedback on Research Compliance Infrastructure

Chancellor Linda Katehi has commissioned an external assessment of research compliance and integrity at UC Davis. To this end, on October 13-15, 2014 we will host a team of five nationally recognized research administrators on campus conducting a peer review of our research compliance structures as part of the National Council of University Research Administrators (NCURA) peer review program. This review, similar in nature to an academic program review, is being done to ensure that we are appropriately organized to advance excellence in research, ensure the ethical conduct of research while also encouraging creative accomplishments with the UC Davis community.

The site visit in October provides an opportunity for the peer reviewers to interact with representatives of all the important constituent groups in the UC Davis research community. The NCURA peer review team would like to meet established faculty whose research requires oversight by research compliance.

The NCURA group has requested 1-3 sessions of up to 20 faculty researchers apiece. Therefore, the following times have been established for this purpose.

Wednesday, October 15, 2014 – location Alumni Center, Founder’s Board Room

Faculty Session 1: 1-1:30 p.m.

Faculty Session 2: 1:30-2 p.m.

Faculty Session 3: 2-2:30 p.m.

Please confirm your availability to participate by August 22, by email to Compliance Analyst Larisa King ([email protected]; 530-752-6550). While we understand that many of you may not be available at the specified time, we are hoping to garner as much participation as possible. NCURA is looking for your unique viewpoints and perspectives and this would be an opportune time to express the challenges and opportunities of our research compliance program.

Additionally, NCURA has requested to meet with junior faculty (faculty who have been conducting between 3-5 years of independent research) at a meeting which has been scheduled to take place on the same day, October 15th, from 2:30-3:15 p.m. If you consider yourself to be a junior faculty member, NCURA is interested in hearing your perspectives as well. Again, please contact Larisa King at [email protected] with your availability by August 22.

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Posted May 28, 2014

Prisoners in Biomedical Research

Dear Research Community,

A gentle reminder that California Penal Code (Section 3502) does not allow for the enrollment of state prisoners into biomedical research. Our state requirement is different from the federal requirement.

A prisoner is defined as: “Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.” [45 CFR part 46.303(c)]

If a research participant is incarcerated after enrollment in biomedical research, review our Standard Operating Procedure, New Information (SOP-24), Section 5.7, for the appropriate steps to notify the IRB as soon as possible.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted March 24, 2014

Avoid Research Personnel Changes Rejection!

Dear Research Community,

Effective April 1, 2014 we will no longer be accepting older versions of the Application for Initial Review (HRP-211) or Research Personnel List forms. New versions of these forms have been available since November 26, 2013. You should start using the new forms immediately.

At continuing review, please check the latest RPL for the study. If the RPL is not listed on the current HRP 211 or Research Personnel List Template, you must submit an updated list using HRP-211 Initial Application or Research Personnel List Template.

All other forms will be rejected at time of submission.

Remember – the current forms require the PI to attest that the personnel on the list have:

Please ensure these requirements are met before you submit a new RPL.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted March 7, 2014

Human Subject Research Training

Don’t let approval of your research be delayed!

We receive many submissions that cannot be approved because the training requirements are not met. Don’t let approval of your submission be delayed. Complete the required training before you send your research to the IRB. Training requirements can be found in the Investigator Manual (HRP-103).

Please note – When the PI signs the Application for Initial Review (HRP-211) and/or the Research Personnel List, he/she is attesting that he/she and all research staff have completed the required training. When this attestation is signed, we shouldn’t be able to find instances where the training is not completed. When we find that the training is not completed, we may need to refer the issue for possible audit.

Sincerely,

IRB Administration

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Posted February 27, 2014

Clarification on Research Personnel List

Dear Research Community,

The IRB Administration would like to provide clarification on the recent enacted changes to reporting and documenting research personnel to our office. Please reference the guidance below as to when to list or not list research personnel by name and within which documents to so.

List research personnel by name within:

• • • HRP-211
      Application for Initial Review

Or if you would like to use Research Personnel List Template in addition to HRP-212

List research personnel by role and qualifications within:

• • • HRP-503
      Protocol
    • HRP-502
      Consent Form, if applicable

Example (HRP-503 Protocol, section 24 “Resources Available”):

Nurse Practitioner: will assist the PI with subject medical examinations and charting. Has participated in previous research studies and is familiar with…..

Study Coordinator: will be directly involved with the subjects recruiting, screening, consenting, scheduling, and communicating along with the preparation and conduction of research procedures. Has previous experience in coordinating large multi-site research and familiar with UCD IRB requirements.

Modifications to the Research Personnel List:

As the individual responsible for the study, Principal Investigators are required to attest that they have verified that all research personnel, involved in the design, conduct, or reporting of the study, have completed the required human subject research training when submitting a modification to their research personnel. In addition, the PI will attest that the individuals have reported conflicts of interest. It is very, very important that PIs ensure that this statement is correct before signing the attestation on the form.

Protocols existing prior to the launch of attestation on February 10, 2014, will not be grandfathered and PIs will be required to submit their updated personnel list utilizing either HRP-211 Initial Application or Research Personnel List Template

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted February 7, 2014

Clarification on Reporting Adverse Events

Dear Research Community,

In our efforts to provide further clarity for reporting of adverse events, we have updated category 2 in our HRP-214 Reportable New Information form with new definitions and criteria for reporting serious, unexpected, and probably related harms.

Updated wording:

Serious harm experienced by a subject or other individual, which in the opinion of the investigator is unexpected and probably related (>50% likely; “Don’t know” = <50%) to the research procedures.

a) A harm is “serious” when it meets any of the following criteria; 1.) results in death; 2.) is life-threatening (place the subject at immediate risk of death from the event as it occurred); 3.) results in inpatient hospitalization or prolongation of existing hospitalization; 4.) results in a persistent or significant disability/incapacity; 5.) results in a congenital anomaly/birth defect; 6.) based upon appropriate medical/psychological judgment, may jeopardize the subject’s health and may require medical, counseling, or surgical intervention to prevent one of the other outcomes listed in this definition; or 7.) results in criminal or civil liability or damaging of the subject’s financial standing, employability, or reputation

b) A harm is “unexpected” when its specificity or severity are inconsistent with risk information previously reviewed and approved by the IRB in terms of nature, severity, frequency, and characteristics of the study population.

c) A harm is “probably related” to the research procedures if in the opinion of the investigator, the research procedures more likely than not caused the harm.

The updated document is now available on the IRB website.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted December 16, 2013

Changes to Research Personnel List

Dear Research Community,

In our continuing efforts to streamline the IRB administration process and forms, we are no longer requiring that each individual research personnel (excluding Principal Investigator) be listed within the research protocols and consent forms. Research protocols will only require you to describe personnel by roles (e.g. coordinator, research assistant, or pharmacist) and the qualifications (e.g. training, experience, oversight) required to perform each role. Including only the roles of the personnel and not the names will allow you to make personnel changes without having to modify the protocol.

In addition, Principal Investigators will now be required to attest that they have verified that all research personnel, involved in the design, conduct, or reporting of the study, have completed the required human subject research training. This attestation will be required at initial review and any subsequent changes to the research personnel.

These changes required revisions to the following documentation:

• • • HRP-211
      Application for Initial Review
    • HRP-213
      Modification
    • HRP-503
      Protocol
    • HRP-090
      Standard Operating Procedures: Informed Consent Process for Research
    • HRP-091
      Standard Operating Procedures: Written Documentation of Consent
    • Research Personnel List Template (NEW)

We believe these changes will have the following positive impacts on the research community:

• • • Reduce IRB review times
    • Reduce delays in approval of research
    • Reduce modification paperwork for research personnel changes

The updated documents are now available on the IRB website. After February 10, 2013 only these new forms will be accepted by our office. Existing approved protocols will be grandfathered in and will not be required to list personnel by roles within the protocol and consent forms.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted November 27, 2013

New IRB Approval Stamp

Dear Research Community,

In our continuing efforts to streamline the IRB Administration processes, we are removing the expiration date from our approval stamp. This small change aligns us with industry practice, and at the same time, reduces the UC Davis research community’s administrative workload.

Here is an example of the new stamp:

We believe that removing the expiration date will have the following positive impacts on the research community:

• • • Reduce the chance that investigators will obtain consent from subjects with an expired consent form.
    • Reduce the number of consent form versions over the life of a study.
    • Reduce subjects’ confusion about study end dates.
    • Reduce renewal paperwork required to be submitted to the IRB.

We will apply the stamp to consent documents only at initial approval and when a modified version is approved. Please note that you must not use a modified informed consent document until that document has been approved and stamped with the new approval date.

Please also note that the informed consent document is the only document that receives an approval stamp. For more information about our document stamping policy, please view our guidance IRB Approval Document Stamping.

We will utilize the new stamp starting on December 2, 2013.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted October 14, 2013

Protocol Expiration Notification Process

Dear Research Community,

The IRB Administration recently started a new process to try to decrease the number of studies that expire.

We are now sending protocol renewal notices at intervals of 120, 90, 60, and 30 days prior to expiration of the study. We will also contact research staff by phone if we haven’t received the continuing review report within 30 days of expiration. We will stop the notifications as soon we receive the required report.

We hope that this new process will decrease the number of expired studies and also decrease the number of “restricted” investigators. You may be aware that PIs who have allowed one or more of their studies to expire are placed on a “restricted list” until they submit the required reports to either renew or close the study. When a PI is on the restricted list, the IRB will not review any submissions of new research from that PI.

Please respond to the notices as early as possible so your study does not expire and your ability to have your research reviewed is not restricted.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted October 10, 2013

IRB Updates

Dear All,

In a constant effort to reduce turnaround times and improve workflow, we are pleased to announce that we have hired three new Biomedical Committee Analysts, in addition to our new IRB Associate Director. Two of our new Biomedical Committee Analysts, Jessica Trask, PhD, and Amanda Carioggia, started in August, and our third Biomedical Committee Analyst, Debbie Leung, started in September. They are still onboarding and will be transitioning into their independent roles in late October/early November. We apologize for any delays you have experienced during this time, and ask for your patience as we complete the onboarding process. Our previous Biomedical Committee Analysts have accepted new positions within the IRB Administration, and we appreciate and look forward to their continued contributions.

Our new IRB Associate Director, Cindy Gates, JD, RN, CIP, started in September. She spent 11 years at Western IRB (WIRB), holding senior leadership positions as the VP of Regulatory Affairs and VP of Operations. She has a strong track record of operational improvements and reducing turnaround times. We believe that we are now well-positioned to meet and exceed the expectations of the research community and sponsors.

We also submitted our AAHRPP application for institutional accreditation in June 2013, and are currently submitting responses to our Step 1 application review. We are expecting a site visit sometime after January 2014, and before May 2014.

In addition, we continue to work on our new KC IRB system, and are currently evaluating programming and implementation timelines.

We are constantly developing new ways to better serve your needs, and appreciate your continued patience while we get our new staff up to speed.

Very sincerely,

Dan

Daniel Redline, BA, CCRP, CIP
Director, IRB Administration
University of California, Davis

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Posted October 9, 2013

2014 Full Board Committee Meeting Dates

Dear Research Community,

The IRB has posted the 2014 Full Board committee meeting dates to our website. We have also posted our new guidelines on how submissions will be assigned to these committees. This information can be located on our About IRB webpage.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,
IRB Administration

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Posted July 18, 2013

CITI Website Unavailable 07/29 – 07/31 Due to System Upgrades

Dear Research Community,

Starting Monday July 29^th at 8 a.m. Pacific Daylight Time, the online human subject research education program website, known as CITI, will be unavailable for approximately two to three days to complete a major software upgrade.

The UCD IRB Administration will generate its normal “CITI and GCP Certified” list on the morning of July 29^th to capture all current certified UCD/UCDHS research personnel prior to shutdown. This list will be available on our website at https://irb.ucdavis.edu/researchers/citi/.

Please have all research personnel complete any and all necessary training modules prior to the shutdown of the CITI website that may delay the approval of your protocols during this time.

During the software upgrade of the website neither the UCD IRB Administration nor CITI will have access to the website.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted July 04, 2013

New FWA and IORG Expiration Dates

Dear Research Community,

We have updated our Federalwide Assurance (FWA) and IRB Organization (IORG) registrations to include the recent changes within the UC Davis IRB Administration. As such, we wanted you to be aware of the new expiration dates for both:

 

FWA #00004557 is approved until June 13, 2018

IORG #0000251 is approved until July 2, 2016

 

For more information about FWAs and IORGs, please visit OHRP.

If you have any additional questions, please do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted June 06, 2013

Open Positions within the IRB

Dear Research Community,

Due to two upcoming internal promotions, and a continued focus on reducing turnaround times, the IRB Administration is looking for three Biomedical (Clinical) Committee Analysts to join our team. Please forward this announcement to others who may be interested:

Positions: IRB Biomedical (Clinical) Committee Analysts

Brief Description: Under general supervision of the Associate Director of the IRB Administration, efficiently manage IRB committee(s); review policies, processes and protocols and provide guidance and analytical support to the IRB, Office of Research, departments and campus units and external organizations/clients. Conduct analysis of large quantities of information and provide policy interpretation, guidance and recommend solutions in resolving time sensitive protocol issues.

Quick Link To This Position: https://www.employment.ucdavis.edu/applicants/jsp/shared/position

Please feel free to contact OR HR at [email protected] if you have any questions or need additional information.

Sincerely,

IRB Administration

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Posted May 16, 2013

Common Audit Findings

Dear Research Community,

Our office works in close collaboration with the Research Compliance and Integrity Unit and their Quality Improvement Auditor has provided us a list of common audit findings in human subjects research. We are sharing the list for educational purposes. These findings are:

Unspecified duration of study (from start to closure) and planned enrollment

Missing documents: consent and regulatory forms

Subjects consented by unapproved research personnel

Subjects consented with expired versions of the consent form

Consent form missing signatures (subject and/or researcher) and dates

Consent form missing answers/initials to the optional questions (future contact for research, specimen banking)

Human subject research continued past the IRB approved duration

Inaccurate reporting of enrollment numbers

These easily avoided situations could lead to unnecessary delays and/or suspension in research and put subjects at risk. Please protect your research subjects by appropriately training your research personnel staff and keeping your research records up to date.

For further information about researcher responsibilities, please take the time to review our Investigator Manual.

If you have any additional questions, do not hesitate to contact our IRB Staff.

Sincerely,

IRB Administration

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Posted May 3, 2013

Tips for Successful Submissions

Dear Research Community,

The following tips and hints from our in-house staff will assist in speeding up review times and reduce IRB reviewer comments:

• • • Within HRP-503 Protocol Template, for any items described in the sponsor’s protocol, grant, contract, or other documents submitted with the application, copy/paste the documentation into the protocol template. This should be quick and will decrease the time our reviewers take trying to locate and verify the information.
    • HRP-502 Consent Form Template contains the California Experimental Subject’s Bill of Rights, which is required for all biomedical research, on the first page. No need to submit a separate document with this information.
    • The IRB Administration no longer requires the creation of separate assent forms or letters of information for minors in research. The existing HRP-502 Consent Form Template contains the documentation for assent of minors under the section titled “Signature Block for Children.” Additional information can be found in 45 CFR Part 46.408.
    • For studies containing multiple consent forms, label the different consent forms within the footer, lower left side, for ease of identification by our office (e.g. parental control group, control group, pregnant women control group, etc.).
    • Pager prefix change – If the consent form your study is utilizing contains a pager number for a contact number and was impacted by this change (from 762- to 816- ), the IRB Administration will allow you to manually cross out the incorrect pager prefix and insert the correct one until the study is up for renewal or requires modification (not related to the pager prefix change). At this time you will be required to update the pager prefix number. Please initial and date the change.
    • Place version dates within the footer, on the left side, of your documentation (e.g. protocols, consent forms, recruitment material, etc.). Version dates should not be changed unless the document itself has been updated. Please do not change the existing IRB document version dates within headers of applications or footers of forms.
    • Please do not submit Checklists or Worksheets with your submissions. These documents have been made available to you as reference material and are not reviewed by the IRB Administration.
    • Please do not submit hand written documentation. This will be rejected and a request for type-written documentation will be requested.

If you have any questions, please contact our IRB Staff.

Sincerely,

IRB Administration

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Posted May 2, 2013

New Information/Form Update

Dear Research Community,

In response to community feedback, and our own quality assessment procedures, we have updated/modified the following to improve processes, procedures, and overall efficiency.

1. Updated Forms and Templates

HRP-212 Continuing Review Progress Report:

• • • Expanded, simplified, and clarified the “Enrollment Status” section.

*Please see the definition of enrollment under section 2

• • • Simplified and clarified the “Current Protocol Status” section.
    • Embedded a response area to “The following questions refer to all sites involved in the protocol since the last IRB continuing review” section.
    • “Brief summary of the progress of the protocol” memo has been replaced with embedded questions.
    • New section, “For IRB Expired Studies Only”, which addresses studies that are submitted to the IRB after their expiration date. Principal Investigators who allow their studies to expire are required to complete the HRP-214 Reportable New Information form and submit it with their renewal.

HRP-502 Consent Form Protocol:

• • • New standard language available for studies using a Certificate of Confidentiality.
    • New 24 hour contact information language for all studies (The IRB Administration is now requiring Principal Investigators to provide participants a 24-hour contact number in the case of an emergency).

HRP-503 Protocol Template:

• • • Updated protocol completion instructions on page 1.
    • The sections “Study-Wide Number of Subjects” and “Number of Subjects” have been condensed into one section for ease of understanding and clarification.
    • The sections “Study-Wide Recruitment Methods” and “Recruitment Methods” have been condensed into one section for ease of understanding and clarification.

2. Definition of “Enrollment”

Due to confusion and misinterpretation of the term “enrollment” amongst the UC Davis research community, the UC Davis IRB Administration has decided to adopt the FDA and industry definition, as follows:

“Subjects that have been consented, met formal inclusion and exclusion criteria, and are scheduled to participate/are participating/or have participated in the research in accordance with the protocol are enrolled within a study”

Adopting this definition will provide consistency of understanding at all levels within the research community.

3. Standard Operating Procedures (SOPs)

The following SOPs have been updated:

• • • HRP-021 Pre Review
    • HRP-024 New Information
    • HRP-033 Designated Faculty Review
    • HRP-034 Designated Faculty Review Conduct
    • HRP-041 IRB Meeting Conduct
    • HRP-043 IRB Meeting Minutes
    • HRP-052 Post Review
    • HRP-063 Expiration of IRB Approval

4. Exempt Studies

The IRB Administration has decided to no longer put expiration dates on studies determined to be exempt. This will only impact studies submitted for initial review and studies coming through for continuing review, going forward. Existing exempt studies with expiration dates still need to be submitted for continuing review. This decision meets all federal, state, and institutional regulations.

If you have any questions, please contact our IRB Staff.

Sincerely,

IRB Administration

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Posted January 4, 2013

New/Updated Forms

Dear Research Community,

A friendly reminder that as of December 3^rd, 2012 the IRB Administration is no longer accepting initial submissions on our “older” forms, please visit our website for our newest applications and templates.

In addition, please be aware that several of our new forms have been recently modified based upon feedback from the research community. To identify a form’s current version date, please look at the date in parenthesis to the right of the form title (i.e. HRP-503 – Protocol (12/26/12)). We highly recommend that you do not save copies of our forms on electronic devices, for they may be outdated the next time you utilize them.

If you have any questions, please contact our IRB Staff.

Sincerely,

IRB Administration